Z-1609-2026 Class II Ongoing
FDA device recall Z-1609-2026 was initiated by Beckman Coulter, Inc. on July 24, 2025 and is designated Class II. Reason for recall: Due to the likely presence of contamination in well(s). The recall status is ongoing. Affected quantity: 685 boxes.
Recall Details
- Product Type
- Devices
- Report Date
- April 1, 2026
- Initiation Date
- July 24, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 685 boxes
Product Description
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.
Reason for Recall
Due to the likely presence of contamination in well(s).
Distribution Pattern
U.S. Nationwide distribution in the states of CA, CO, IN, MA, MD, MN, MO, NC, NJ, OK, PA, and TX.
Code Information
Catalog Number: C42464 UDI-DI code: 15099590731212 Lot Number: 2026-01-03