FDA recall, , Moderate risk
Beckman Coulter MicroScan Neg MIC 3J
MicroScan Neg MIC 3J is missing a drug in well 4/4 but contains double the amount of antibiotics.
Summary by Recall Canary from the FDA notice
What happened
Beckman Coulter, Inc., of West Sacramento, California, recalled MicroScan Neg MIC 3J REF C54814 due to a manufacturing issue - missing a drug in well 4/4 but contain double the amount of antibiotics. The recall began June 25, 2025, and the FDA added it to its Enforcement Report on April 3, 2026. The product was distributed internationally in Japan, with 688 boxes of 20 panels each affected.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its lot code matches.
MicroScan Neg MIC 3J REF C54814
- Lot code
- 2025-08-23
Recall details
- Company began the recall
- Sold in
International distribution in the country of Japan.
- Company
- Beckman Coulter, Inc.West Sacramento, California
- Hazard
- Manufacturing problem
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98553
- Recall number
- Z-1772-2026
- Quantity recalled
- 688 boxes (20 panels per box)
All recalls from Beckman Coulter, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
