—#202803

Product

remel TODD HEWITT W. CNA (LIM BROTH), REF R064810; used to isolate Group B Streptococci form clinical specimens containing mixed bacterial flora

FDA product code: JSD — Culture Media, Selective Broth
Device class: Class 1
Medical specialty: Microbiology
510(k) numbers: K871447
Affected lot / code info: UDI/DI 00848838010064, lot 668255, Exp. 04/26/2024

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Remel, Inc
Address: 12076 Santa Fe Trail Dr, Lenexa, Kansas 66215-3519

Distribution

Distribution pattern: US Nationwide Distribution

Timeline

Recall initiated: 2023-08-14
Posted by FDA: 2023-09-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #202803. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.