Class I - Dangerous
Pouches may not have been sealed during packing.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
A field correction was issued by the firm for VITROS TSH reagent lot 5040 due to a higher than expected frequency of customer calibration curves falling outside of the calibration quality parameters and therefore unusable to process samples. Customers using VITROS TSH Lot 5040 will potentially experience an unexpected increase in the unsuccessful calibrations potentially causing a delay in testing and reporting results for VITROS TSH.
MultiQuant MD software where under certain conditions a user can be presented with incorrect quantitative results when using the Sum Multiple Ions feature.
Class I - Dangerous
Pouches may not have been sealed during packing.
The Perioscopy Sheaths are currently provided with a label that indicates the Sheath has a 3 year shelf-life/expiry date. Danville Materials has become aware that validation data are not available to support the 3-year shelf-life/expiration dating claim.
Class I - Dangerous
Pouches may not have been sealed during packing.
Class I - Dangerous
Pouches may not have been sealed during packing.
Class I - Dangerous
Pouches may not have been sealed during packing.
Potential for compromise of the package resulting in a breach of the sterile barrier
Conical EP Healing Cap Dental implants
Biomet 3i
Class I - Dangerous
Pouches may not have been sealed during packing.
Potential for compromise of the package resulting in a breach of the sterile barrier
Class I - Dangerous
Pouches may not have been sealed during packing.
Class I - Dangerous
Pouches may not have been sealed during packing.
Class I - Dangerous
Pouches may not have been sealed during packing.
Gingihue 15 degrees Pre-Angled Post 4mm(D) x 5mm(P) x 2mm(H) Item: PAP452G Dental implants
Biomet 3i
Class I - Dangerous
Pouches may not have been sealed during packing.
Potential for compromise of the package resulting in a breach of the sterile barrier
Class I - Dangerous
Pouches may not have been sealed during packing.
While merging exams in a test instance, merges carry forward in the production system, when the middle tier is configured to the wrong IP address of the Centricity Exam Manager. When a current and historical exam are opened at the same time, the system asynchronously tries to access the operation specifying how each image should be grouped, causing random image-series grouping errors.
OraQuick Ebola Rapid Antigen Test, Product Code 3001-2807; Intended for the qualitative detection of antigens for Ebola viruses.
OraSure Technologies
Class I - Dangerous
Failed stability testing at 8 months. This lot produced intermittent false negative results for the positive kit control with devices stored at 30C conditions.
Class I - Dangerous
Pouches may not have been sealed during packing.