remel TODD HEWITT W. CNA (LIM BROTH), REF R064810; used to isolate Group B Streptococci form clinical specimens containing mixed bacterial flora
This recall is currently active, issued September 8, 2023. It was issued by Remel Inc.
- Company
- Remel Inc
- Recall Initiated
- August 14, 2023
- Posted
- September 8, 2023
- Recall Number
- Z-2531-2023
- Quantity
- 139 units (13,900 tests)
- Firm Location
- Lenexa, KS
- Official Source
- View on FDA website ↗
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
US Nationwide Distribution
Lot / Code Info
UDI/DI 00848838010064, lot 668255, Exp. 04/26/2024
Root Cause
Under Investigation by firm
Action Taken
ThermoFisher SCIENTIFIC disseminated a "Medical Device Field Action Recall" to its consignees on 08/14/2023 by US mail. The notice explained the problem, the risk to health, and requested the following actions be taken: - Destroy any remaining affected product in inventory; - A review of reported test results should be evaluated by an appropriate technical expert; - Pass the notice to all who need to be aware within your organization or to any organization where the potentially affected products have been transferred; - Keep the notice on file. The firm will replace the product. If you have any questions, please contact our Technical Services Department at 800-255-6730 (US) or email microbiology.ts.us@thermofisher.com.