Class I - Dangerous
Products may contain contamination, which may result in a darker or brown media color.
Remel
83 recalls • • Categories: Other Medical Devices, Infusion Pumps, Diagnostic Equipment, Surgical Instruments
Class I - Dangerous
The products may contain surface and subsurface contamination of Listeria monocytogenes.
Class I - Dangerous
The products may contain surface and subsurface contamination of Listeria monocytogenes.
Class I - Dangerous
The products may contain surface and subsurface contamination of Listeria monocytogenes.
Class I - Dangerous
The products may contain surface and subsurface contamination of Listeria monocytogenes.
Class I - Dangerous
Product may have an off color affecting perfomance
Class I - Dangerous
Power supply unit for Zebra Printers used with the device can potentially overheat or cause a fire hazard.
Class I - Dangerous
Product may contain surface and subsurface contamination of Listeria monocytogenes which is typically visible immediately upon removal from the packaging, appearing on the blood side of the biplate.
Class I - Dangerous
Product may contain surface and subsurface contamination of Listeria monocytogenes which is typically visible immediately upon removal from the packaging, appearing on the blood side of the biplate.
Class I - Dangerous
A color change of the solution within the dropper can occur from orange-yellow to light yellow resulting in out-of-specification fluorescent stain results.
Class I - Dangerous
On lot of Todd Hewitt Broth w/CNA (LIM) may exhibit no recovery of target organism during customer QC testing or use with patient samples
Class I - Dangerous
The test medium may not perform as intended.
Class I - Dangerous
An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp., Morganella Morganii) when tested with doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam and aztreonam.
Class I - Dangerous
An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp., Morganella Morganii) when tested with doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam and aztreonam.
Class I - Dangerous
An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp., Morganella Morganii) when tested with doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam and aztreonam.
Class I - Dangerous
An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp., Morganella Morganii) when tested with doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam and aztreonam.
Class I - Dangerous
An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp., Morganella Morganii) when tested with doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam and aztreonam.
Class I - Dangerous
An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp., Morganella Morganii) when tested with doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam and aztreonam.
Class I - Dangerous
An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp., Morganella Morganii) when tested with doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam and aztreonam.
Class I - Dangerous
An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp., Morganella Morganii) when tested with doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam and aztreonam.
Class I - Dangerous
An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp., Morganella Morganii) when tested with doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam and aztreonam.
Class I - Dangerous
There are lower than expected MICs for some gram negative species.
Class I - Dangerous
Out of Specification
The media allows growth of E. faecalis ATCC 29212 with blackening of the media.
When tested with H. influenza ATCC 49247 and ATCC 49766 both organisms may exhibit lighter than normal growth making zones difficult to measure.
When tested with H. influenza ATCC 49247 and ATCC 49766 both organisms may exhibit lighter than normal growth making zones difficult to measure.
Class I - Dangerous
The blood agar side of the bi-plate may not grow some patient isolates or QC organisms as intended.
Class I - Dangerous
Potential for out of range microbial results
Class I - Dangerous
Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 57 days after date of manufacturing. Expiration date is shortened from 7 months to 56 days.
Class I - Dangerous
Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 days.
Class I - Dangerous
Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 days.
Class I - Dangerous
Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 days.
Class I - Dangerous
Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 57 days after date of manufacturing. Expiration date is shortened from 7 months to 56 days.
Class I - Dangerous
Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 57 days after date of manufacturing. Expiration date is shortened from 7 months to 56 days.
Class I - Dangerous
Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 days.
Class I - Dangerous
Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 days.
Class I - Dangerous
Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 57 days after date of manufacturing. Expiration date is shortened from 7 months to 56 days.
Class I - Dangerous
Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 days.
Class I - Dangerous
Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 days.
Class I - Dangerous
Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 days.
Class I - Dangerous
Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 days.
Class I - Dangerous
Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 days.
Class I - Dangerous
Products have intermittently failed performance testing during stability studies with various anaerobic microorganisms.
Class I - Dangerous
Products have intermittently failed performance testing during stability studies with various anaerobic microorganisms.
Class I - Dangerous
Products have intermittently failed performance testing during stability studies with various anaerobic microorganisms.
The serum may fail to agglutinate within the specified minimum reaction time.
Class I - Dangerous
Product may have incorrect cation information detailed on the product label.
Confirmed complaint of surface contamination of Listeria monocytogenes.
Class I - Dangerous
Test organisms exhibit poor growth when grown using the test agar. The poor growth can give users incorrect AST zones when performing susceptibility tests.
Class I - Dangerous
Individual bottles of product may produce weak beta-lactamase reactions. Use may result in delayed or false negative reporting.
Antibiotic concentration may be insufficient which may result in incorrect test results.
A reagent present may produce weak or slow reactions; continued use may result in a failure to identify target species.
A reagent present may produce weak or slow reactions; continued use may result in a failure to identify target species.
Use of the recalled product may result in false positive reports.
Use of the recalled product may result in false positive reports.
Product may be contaminated with Listeria monocytogenes.
Use of the product may not provide adequate recovery and could result in false negative identification of Legionella pneumophila.
Class I - Dangerous
Use of the product could result in inadequate recovery of Legionella pneumophila which could result in false negative reporting.
The product may appear cloudy or discolored and may not perform correctly in presumptive diagnosis of mycobacterial disease.
A reagent within the test may return false negative results.
A reagent within the test may return false negative results.
Class I - Dangerous
Recalled product may not provide adequate recovery of Legionella pneumophila when used as directed and may result in false negative identification of Legionella pneumophila.
Class I - Dangerous
Bottles did not provide positive signals within the time frame of the quality control specification for one of two strains of Streptococcus pneumoniae.
A reagent contained within the product may return false negative results.
A reagent contained within the product may return false negative results.
Some of the discs may not be impregnated with the antibiotic.
The product may contain high levels of microbial contamination
Cartridges may contain individual discs which were not impregnated with antibiotic.
Cartridges may contain individual discs which were not impregnated with antibiotic.
Cartridges may contain individual discs which were not impregnated with antibiotic.
Cartridges may contain individual discs which were not impregnated with antibiotic.
Individual discs in the lot may not be sufficiently impregnated with antibiotic, resulting in smaller than expected zone sizes.
The product may give weak or false negative test results.
Boxes labeled as CIP5 may contain cartridges of AMP5.
The two reagents supplied in the RapID Yeast Plus System kit (Reagent A and Reagent B) are mislabeled. The labels were reversed.
The product may give weak or false negative test results.
Use of affected lots may give false indication of susceptibility to Nitrofurantoin.
Flu A+ Control Swabs incorrectly give Flu A- results when used for quality control testing with the Xpect Flu A&B test kit.
The product may contain low level microbial contamination which could result in incorrect results.
The firm is recalling the products due to a potential for false negative test results.
The firm is recalling the products due to a potential for false negative test results.
The firm is recalling the product because the cartridges may contain discs that have an insufficient dose of antibiotic.
The firm is recalling the product due to some cartridges may contain individual discs that are not impregnated with antibiotic. The firm notified their customers of the recall with a notification letter and requested a confirmation fax back of receipt.