FDA DevicesClass II
MicroScan Neg MIC 3J REF C54814
Published: April 15, 2026Recall ID: Z-1772-2026Category: devicesCountry: US
Reason for Recall / Hazard
Due to a manufacturing issue - missing a drug in well 4/4 but contain double the amount of antibiotics
Product Description & Identification
MicroScan Neg MIC 3J REF C54814
Additional Source Details
| Field | Value |
|---|---|
| City | West Sacramento |
| State | CA |
| Event id | 98553 |
| Address 1 | 2040 Enterprise Blvd |
| Code info | Catalog Number: C54814 UDI code: N/A Lot Number: 2025-08-23 |
| Postal code | 95691-3427 |
| Report date | 20260415 |
| Product type | Devices |
| Product quantity | 688 boxes (20 panels per box) |
| Reason for recall | Due to a manufacturing issue - missing a drug in well 4/4 but contain double the amount of antibiotics |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20250625 |
| Center classification date | 20260403 |
Overview
- Recalling FirmBeckman Coulter, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionInternational distribution in the country of Japan.