CLASS II ONGOING Device recall · Reported 18 Jun 2025 · FDA Enforcement Report
Thermo Scientific Sensititre Cation Adjusted AutoRead recalled by Remel
Remel is recalling Thermo Scientific Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth w/ TES w, distributed nationwide in the US. The recall was initiated on 1 May 2025 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-1947-2025
- FDA event ID
- 96810
- Recalling firm
- Remel, Lenexa, KS
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 1 May 2025
- FDA classified
- 11 Jun 2025
- Reported
- 18 Jun 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 1 May 2025 | Recall initiated by company | |
| 11 Jun 2025 | Classified by FDA | +41 days |
| 18 Jun 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product may have an off color affecting perfomance
Product as listed by the FDA
Thermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth w/ TES w/ Lysed Horse Blood, REF CP11410; invitro diagnostic device
Where it was distributed
Worldwide - US Nationwide distribution in the states of AL, GA, KY, VA and the countries of Canada, UK.
Questions about this recall
Why was it recalled?
Product may have an off color affecting perfomance
Which lots are affected?
UDI/DI 848838018855, lot 226414
Where was it sold?
Worldwide - US Nationwide distribution in the states of AL, GA, KY, VA and the countries of Canada, UK.
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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