CLASS II ONGOING Device recall · Reported 15 Apr 2026 · FDA Enforcement Report
MicroScan Neg MIC 3J recalled by Beckman Coulter
Beckman Coulter is recalling MicroScan Neg MIC 3J. The recall was initiated on 25 Jun 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-1772-2026
- FDA event ID
- 98553
- Recalling firm
- Beckman Coulter, West Sacramento, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 25 Jun 2025
- FDA classified
- 3 Apr 2026
- Reported
- 15 Apr 2026
- Type
- Voluntary: Firm initiated
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 25 Jun 2025 | Recall initiated by company | |
| 3 Apr 2026 | Classified by FDA | +282 days |
| 15 Apr 2026 | 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
Due to a manufacturing issue - missing a drug in well 4/4 but contain double the amount of antibiotics
Product as listed by the FDA
MicroScan Neg MIC 3J REF C54814
Where it was distributed
International distribution in the country of Japan.
Questions about this recall
Why was it recalled?
Due to a manufacturing issue - missing a drug in well 4/4 but contain double the amount of antibiotics
Which lots are affected?
Catalog Number: C54814 UDI code: N/A Lot Number: 2025-08-23
Where was it sold?
International distribution in the country of Japan.
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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