remel TODD HEWITT W. CNA (LIM BROTH), REF R064810; used to isolate Group B Streptococci form clinical specimens containi
FDA device recall Z-2531-2023 · posted 2023-09-08 · Open, Classified
Recall details
- Recalling firm
- Remel, Inc
- 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
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- JSD
- Quantity affected
- 139 units (13,900 tests)
- Distribution
- US Nationwide Distribution
- Date initiated
- 2023-08-14
- Date posted
- 2023-09-08
- Location
- Lenexa, KS
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TODD HEWITT W/CNA (LIM BROTH) (K871447) | Remel Co. | 1987-05-13 |