FDA Medical devices recall ·
MicroScan Neg MIC 3J recall
- Recall number
- Z-1772-2026
- Date
- (initiated June 25, 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
- 688 boxes (20 panels per box)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
MicroScan Neg MIC 3J REF C54814
Why was it recalled?
Due to a manufacturing issue - missing a drug in well 4/4 but contain double the amount of antibiotics
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: C54814 UDI code: N/A Lot Number: 2025-08-23
Distribution
International distribution in the country of Japan.
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-1772-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.