CLASS II ONGOING Device recall · Reported 20 Sep 2023 · FDA Enforcement Report
Todd Hewitt W recalled by Remel
Remel is recalling Todd Hewitt W. Cna (lim Broth), distributed nationwide in the US. The recall was initiated on 14 Aug 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2531-2023
- FDA event ID
- 92880
- Recalling firm
- Remel, Lenexa, KS
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 14 Aug 2023
- FDA classified
- 8 Sep 2023
- Reported
- 20 Sep 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 14 Aug 2023 | Recall initiated by company | |
| 8 Sep 2023 | Classified by FDA | +25 days |
| 20 Sep 2023 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Product as listed by the FDA
remel TODD HEWITT W. CNA (LIM BROTH), REF R064810; used to isolate Group B Streptococci form clinical specimens containing mixed bacterial flora
Where it was distributed
US Nationwide Distribution
Questions about this recall
Why was it 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
Which lots are affected?
UDI/DI 00848838010064, lot 668255, Exp. 04/26/2024
Where was it sold?
US Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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