FDA DevicesClass II
MicroScan Neg MIC 56 REF C42464 UDI-DI code: 15099590731212 MicroScan panels...
Published: April 1, 2026Recall ID: Z-1609-2026Category: devicesCountry: US
Reason for Recall / Hazard
Due to the likely presence of contamination in well(s).
Product Description & Identification
MicroScan Neg MIC 56 REF C42464 UDI-DI code: 15099590731212 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 MIC 56 REF C42464 UDI-DI code: 15099590731212 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 | 98555 |
| Address 1 | 2040 Enterprise Blvd |
| Code info | Catalog Number: C42464 UDI-DI code: 15099590731212 Lot Number: 2026-01-03 |
| Postal code | 95691-3427 |
| Report date | 20260401 |
| Product type | Devices |
| Product quantity | 685 boxes |
| Reason for recall | Due to the likely presence of contamination in well(s). |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20250724 |
| Initial firm notification | Letter |
| Center classification date | 20260320 |
Overview
- Recalling FirmBeckman Coulter, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionU.S. Nationwide distribution in the states of CA, CO, IN, MA, MD, MN, MO, NC, NJ, OK, PA, and TX.