Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 13–21 of 21 recalls
Incorrect labeling in which the front red pouch label did not match the actual size of the medical device. The label on the front of the scope incorrectly states 5.0/2.2 while the back label, shipping box and product ins…
Identified faulty cartridges. If such a faulty cartridge is used for sample testing, false test results could occur.
One component of the kit was shipped with an expiration date of 30Sep2024 while the Certificate of Analysis (COA) indicated an expiration date of 30Apr2025.
Potential for hole in package compromising sterility of the medical kit.
Potential for hole in package compromising sterility of the medical kit.
Potential for hole in package compromising sterility of the medical kit.
Potential for hole in package compromising sterility of the medical kit.
Potential for hole in package compromising sterility of the medical kit.
Potential for signal drift in specific lots of BD PCR Cartridges.