Remel, Inc remel TODD HEWITT W. CNA (LIM BROTH), REF R064810; used to isolate Group B Streptococci form clinical specimens containing mixed bacterial flora Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
remel TODD HEWITT W. CNA (LIM BROTH), REF R064810; used to isolate Group B Streptococci form clinical specimens containing mixed bacterial flora
Brand
Remel, Inc
Lot Codes / Batch Numbers
UDI/DI 00848838010064, lot 668255, Exp. 04/26/2024
Products Sold
UDI/DI 00848838010064, lot 668255, Exp. 04/26/2024
Remel, Inc is recalling remel TODD HEWITT W. CNA (LIM BROTH), REF R064810; used to isolate Group B Streptococci form clinica due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026