remel TODD HEWITT W. CNA (LIM BROTH), REF R064810 recallZ-2531-2023 · Remel, Inc · initiated Aug 14, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Remel, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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
FDA root cause category: Under Investigation by firm
What the company is doing
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].
Recall details
- Recall number
- Z-2531-2023
- Status
- Open, Classified
- Initiated by the company
- Aug 14, 2023
- Posted by the FDA
- Sep 8, 2023
- Recalling firm
- Remel, Inc
- Quantity
- 139 units (13,900 tests)
- Product code
- JSD
- FDA submissions
- K871447
- Distribution
- US Nationwide Distribution
Product description
remel TODD HEWITT W. CNA (LIM BROTH), REF R064810; used to isolate Group B Streptococci form clinical specimens containing mixed bacterial flora
Code information (models, lots, serial numbers)
UDI/DI 00848838010064, lot 668255, Exp. 04/26/2024
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- REMEL R064810Remel, Inc. · Culture Media, Selective Broth1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page