Device product
remel TODD HEWITT W. CNA (LIM BROTH), REF R064810; used to isolate Group B Streptococci form clinical specimens containing mixed bacterial flora
Z-2531-2023
Product summary
- Firm
- Remel, Inc
- Event
- Event 92880
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 139 units (13,900 tests)
- Official record key
device-enforcement:Z-2531-2023
Official wording
Reason: 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
Code information: UDI/DI 00848838010064, lot 668255, Exp. 04/26/2024
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
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