Abbott ARCHITECT Creatine Kinase, IVD, REF 7D6341.
Abbott Laboratories
The product has a stability issue which may lead to an error code indicating "Unable to calculate result, reaction check failure" and/or Quality Control results out of range low.
95,050 total recalls in our database
Abbott Laboratories
The product has a stability issue which may lead to an error code indicating "Unable to calculate result, reaction check failure" and/or Quality Control results out of range low.
The product contains a misprinted expiration date on the peel pack. Both were printed as "180615", which is the lot number. The Lot number is correct.
Two lengths of the 6.5mm RingLoc Hip System Self-Tapping Bone Screw may have the potential for the 30mm screws to be packaged as 20mm screws and vice versa.
Advanced Bionics
The sound processors were loaded with the incorrect firmware.
Advanced Bionics
The sound processors were loaded with the incorrect firmware.
Conformis
The labeling of the boxes and sterile pouches did not match the contents.
Two lengths of the 6.5mm RingLoc Hip System Self-Tapping Bone Screw may have the potential for the 30mm screws to be packaged as 20mm screws and vice versa.
When racks are front-loaded onto the sample presentation unit while samples from the automation line are being processed, a scheduling error within the software can cause mishandling of samples during the creation of an aliquot and lead to incorrect results being generated. Affected samples typically yield non-reproducible falsely decreased results by up to 100%, however the potential for falsely elevated results cannot be ruled out.
O-Two Medical Technologies
There is a potential for the unit to catch fire due to one of the screen retaining screws being incorrectly inserted. Due to this improper screw insertion the screw sat higher than normal allowing it to contact the underside of the main board causing the screw to rub against the bottom side of the board, wearing away the insulation layer and creating a short circuit.
Abbott Laboratories
The product has a stability issue which may lead to an error code indicating "Unable to calculate result, reaction check failure" and/or Quality Control results out of range low.
O-Two Medical Technologies
There is a potential for the unit to catch fire due to one of the screen retaining screws being incorrectly inserted. Due to this improper screw insertion the screw sat higher than normal allowing it to contact the underside of the main board causing the screw to rub against the bottom side of the board, wearing away the insulation layer and creating a short circuit.
Lack of an adequate sterilization validation
When racks are front-loaded onto the sample presentation unit while samples from the automation line are being processed, a scheduling error within the software can cause mishandling of samples during the creation of an aliquot and lead to incorrect results being generated. Affected samples typically yield non-reproducible falsely decreased results by up to 100%, however the potential for falsely elevated results cannot be ruled out.
O-Two Medical Technologies
There is a potential for the unit to catch fire due to one of the screen retaining screws being incorrectly inserted. Due to this improper screw insertion the screw sat higher than normal allowing it to contact the underside of the main board causing the screw to rub against the bottom side of the board, wearing away the insulation layer and creating a short circuit.
Cypress Medical Products
Products were denied Clinical Laboratory Improvement Amendments (CLIA) waiver approval by the FDA, due to the packaging being too similar to domestically sourced products under the same branded label.
KTM AG, of Austria
The throttle can become stuck in the open position, posing a crash hazard to the rider.
Marpac, LLC, of Wilmington, N.C.
The sound machine's internal battery can leak and cause an electrical short, posing a burn hazard.
Sakar International
The massage balls can leak or rupture during or after microwaving, posing a burn hazard to consumers.
Utz Quality Food, LLC is initiating a recall of Bachman Original Twist Pretzels,10 oz.Bag (flexible film) Net Wt.: 10 oz., UPC: 0 77817 10580 8 , because of Undeclared milk allergen. Butter Twist pretzels mistakenly packaged into regular Pretzel Twist bags.
Risk of Hepatitis A exposure.