FDA recall, , Moderate risk
Beckman Coulter MicroScan Neg MIC 56 Panels
MicroScan panels may be contaminated in some wells.
Summary by Recall Canary from the FDA notice
What happened
Beckman Coulter, Inc., of West Sacramento, California, recalled MicroScan Neg MIC 56 REF C42464 panels because of the likely presence of contamination in well(s). The recall began July 24, 2025, and was added to the FDA's Enforcement Report on March 20, 2026. The 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.
The recalled product was distributed in California, Colorado, Indiana, Massachusetts, Maryland, Minnesota, Missouri, North Carolina, New Jersey, Oklahoma, Pennsylvania, and Texas.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the UDI-DI and lot code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
MicroScan Neg MIC 56 REF C42464 UDI-DI code: 15099590731212 MicroScan panels
- UDI-DI
- 15099590731212
- Lot code
- 2026-01-03
Recall details
- Company began the recall
- Sold in
U.S. Nationwide distribution in the states of California, Colorado, Indiana, Massachusetts, Maryland, Minnesota, Missouri, North Carolina, New Jersey, Oklahoma, Pennsylvania, and Texas.
- Company
- Beckman Coulter, Inc.West Sacramento, California
- Hazard
- Contamination
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98555
- Recall number
- Z-1609-2026
- Quantity recalled
- 685 boxes
All recalls from Beckman Coulter, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
