Every recall we track for Biocare Medical, LLC — 5 in all — plus the complaints and injury reports the public filed about them.
Biocare Medical recalls intelliPATH Universal HRP Detection Kits with DAB buffer that may cause weak or no staining, leading to test failures. Affected kits include specific model numbers and lot codes.
Biocare Medical recalls IntelliPath FLX automated staining instruments with software version 3.5.3.1 due to potential unintended movement that could cause damage or liquid spills. Affected units include specific US and OUS serial numbers.
Biocare Medical recalls 4plus Streptavidin HRP Label (HP604H) due to potential invalid test results. This may cause patient tissue consumption and delayed diagnosis. Affected units have specific lot numbers.
Biocare Medical recalls Vulcan Fast Red Chromogen Kit 2 (FR805-5L, FR805S) due to stability issues with raw materials causing chromogen failure in IHC procedures.
Biocare Medical recalls URO-3 Triple Stain (CD44 + p53) with CK20 kits due to incorrect staining patterns from mislabeled components. Affected kits may lead to inaccurate cancer diagnosis results.
