Recall archive / FDA device enforcement
MicroScan Neg MIC 3J REF C54814 — FDA record Z-1772-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jun 25, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- MicroScan Neg MIC 3J REF C54814
- Reason
- Due to a manufacturing issue - missing a drug in well 4/4 but contain double the amount of antibiotics
- Classification
- Class II
- Recalling firm
- Beckman Coulter, Inc.
- Quantity
- 688 boxes (20 panels per box)
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1772-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Catalog Number: C54814 UDI code: N/A Lot Number: 2025-08-23 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
International distribution in the country of Japan.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Apr 15, 2026
- Recall initiation date
- Jun 25, 2025
- Center classification date
- Apr 3, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.