MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 ...
Reason for Recall / Hazard
Due to manufacturing issue (incorrectly processing) with in vitro multidrug resistant test.
Product Description & Identification
MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended Use- For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.
Affected Products
MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended Use- For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.
Additional Source Details
| Field | Value |
|---|---|
| City | West Sacramento |
| State | CA |
| Event id | 98562 |
| Address 1 | 2040 Enterprise Blvd |
| Code info | Catalog Number: C32368 UDI-DI code: 15099590720568 Lot Number: 2026-05-08 |
| Postal code | 95691-3427 |
| Report date | 20260415 |
| Product type | Devices |
| Product quantity | 3 boxes |
| Reason for recall | Due to manufacturing issue (incorrectly processing) with in vitro multidrug resistant test. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20250908 |
| Initial firm notification | Letter |
| Center classification date | 20260408 |
Overview
- Recalling FirmBeckman Coulter, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionInternational distribution to the country of Poland.