Z-2531-2023Class II

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

Name: Z-2531-2023 remel TODD HEWITT W. CNA (LIM BROTH), REF R064810; used to isolate Group B Streptococci form clinical...
Creator: Remel, Inc
Published: 2023-08-14
License: https://open.fda.gov/license/

Remel Inc / initiated 2023-08-14 / Open, Classified

FDA source

Remel, Inc began a recall of remel TODD HEWITT W. CNA (LIM BROTH), REF R064810; used to isolate Group B Streptococci form clinical specimens containing mixed bacterial flora on 2023-08-14. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2531-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-08-14
Posted: 2023-09-08
Recalling firm: Remel Inc
Product: remel TODD HEWITT W. CNA (LIM BROTH), REF R064810; used to isolate Group B Streptococci form clinical specimens containing mixed bacterial flora
Product code: JSD Culture Media, Selective Broth
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
FDA root cause: Under Investigation by 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].
Quantity in commerce: 139 units (13,900 tests)
Distribution: US Nationwide Distribution
Product codes and lots: UDI/DI 00848838010064, lot 668255, Exp. 04/26/2024

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2531-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2531-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-20	2023-09-08

Product code JSD

K871447Class ITodd Hewitt W/cna (Lim Broth)Remel Co. / cleared 1987-05-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)