Z-2531-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- September 20, 2023
- Initiation Date
- August 14, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 139 units (13,900 tests)
Product Description
remel TODD HEWITT W. CNA (LIM BROTH), REF R064810; used to isolate Group B Streptococci form clinical specimens containing mixed bacterial flora
Reason for Recall
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
Distribution Pattern
US Nationwide Distribution
Code Information
UDI/DI 00848838010064, lot 668255, Exp. 04/26/2024