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Open, Classified

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

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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