Lower riskMedical device recall · FDA · Published August 14, 2023
Remel Todd Hewitt Broth Recall: Risk of False Negative Results in Bacterial Testing
Remel recalls Todd Hewitt Broth (lot 668255) used for Group B Strep testing due to potential false negatives in QC tests. Affected units may not detect target bacteria correctly.
“Remel Todd Hewitt Broth Recall: Risk of False Negative Results in Bacterial Testing.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57488-remel-todd-hewitt-broth-recall-risk-of-false-negative-results. Based on FDA recall #Z-2531-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2531-2023%22&limit=1).
The FDA announced on August 14, 2023, that Remel, Inc. is recalling Todd Hewitt Broth with CNA (LIM) due to potential failure to recover target organisms. The agency issued recall number Z-2531-2023 for the Class II device.
How to tell if you have it
Brand: Remel
Product: TODD HEWITT W. CNA (LIM BROTH)
Reference: R064810
Lot code: 668255
Expiration date: 04/26/2024
UDI/DI: 00848838010064
Quantity: 139 units (13,900 tests)
Distribution: US Nationwide
The hazard
The recalled lot may exhibit no recovery of the target organism during customer quality control testing or use with patient samples. This issue affects the product's ability to isolate Group B Streptococci from clinical specimens containing mixed bacterial flora.
Context
GovInfoNow's records show Remel, Inc has issued 22 other recalls since November 2, 2017. Recent similar recalls include the Remel GC Agar Base Recall on June 3, 2026, and the Remel Yeastone Broth Recall on March 24, 2026. Other recent recalls of similar products include the Remel Neisseria meningitidis Gp C 2ml/VL recall (July 17, 2026), the Remel Oxoid Agglutinating Sera Recall (March 25, 2026), and the Quidel QuickVue Strep A Test Recall (April 6, 2026).
How to tell if you have this one
Check for the lot number 668255 on the packaging. The product is labeled as Todd Hewitt W. CNA (LIM) Broth with expiration date 04/26/2024.
Brand
Remel
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Lot Number
Look for lot number 668255 on the packaging to confirm if your product is affected.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide Distribution” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 37 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2531-2023 (August 14, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2531-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.