remel TODD HEWITT W. CNA (LIM BROTH), REF R064810; used to isolate Group B Streptococci form clinical specimens containing mixed bacterial flora
FDA Recall Z-2531-2023 · Posted 2023-09-08
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Recalling FirmRemel, Inc
Recall StatusOpen, Classified
Product CodeJSD
Date Initiated2023-08-14
Product Quantity139 units (13,900 tests)
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
Firm Action
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 [email protected].
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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