Beckman Coulter, Inc.: Panels, Test, Susceptibility, Antimicrobial
Recall Summary Beckman Coulter is recalling MicroScan Neg MIC 56 test panels used to identify bacteria and test their resistance to antibiotics because some wells in the panels may be contaminated. The affected product was distributed nationwide to clinical laboratories and healthcare facilities. This is a Class II recall, meaning the contamination could potentially affect test results but poses a lower-level risk compared to Class I recalls.
- Recalling firm
- Beckman Coulter, Inc.
- 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.
- Reason
- Due to the likely presence of contamination in well(s).
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2025-07-24
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- U.S. Nationwide distribution in the states of CA, CO, IN, MA, MD, MN, MO, NC, NJ, OK, PA, and TX.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/2fafc44f-8c17-454c-ab86-e527baacbe8b