FDA Medical devices recall ·
MicroScan Neg MIC 56 recall
- Recall number
- Z-1609-2026
- Date
- (initiated July 24, 2025)
- Company / brand
- Beckman Coulter, Inc.
2040 Enterprise Blvd, West Sacramento, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 685 boxes
- Hazard tags
- Microbial contamination
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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.
Why was it recalled?
Due to the likely presence of contamination in well(s).
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Catalog Number: C42464 UDI-DI code: 15099590731212 Lot Number: 2026-01-03
Distribution
U.S. Nationwide distribution in the states of CA, CO, IN, MA, MD, MN, MO, NC, NJ, OK, PA, and TX.
States: California Colorado Indiana Massachusetts Maryland Minnesota Missouri North Carolina New Jersey Oklahoma Pennsylvania Texas
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1609-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.