Recall Z-1609-2026
Beckman Coulter, Inc. · initiated July 24, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Catalog Number: C42464 UDI-DI code: 15099590731212 Lot Number: 2026-01-03
Reason for recall
Due to the likely presence of contamination in well(s).
FDA-determined cause: Material/Component Contamination
Action taken
On 07/24/2025, the firm sent via mail/email an "URGENT MEDICAL DEVICE RECALL" Letter to customers informing them that Beckman Coulter has received reports that when testing clinical isolates there was no growth observed in Ceftazidime (Caz) 1, 8 and 16 mg/mL wells; however, growth was observed in the 4 mg/mL well with multiple panels from this lot. Upon further investigation, it was confirmed the growth was Bacillus spp. and not the clinical isolates being tested. Customers are instructed to: -Consider reviewing previous Caz antimicrobial test results from this lot for any spot growth detection (e.g., isolates with no growth in in Caz 1, 8 and 16 mg/mL wells and growth in the 4 mg/mL well or if there is an unusual increase in Caz MIC values). -Discontinue use of MicroScan Neg MIC 56 Lot 2026-01-03 For any questions regarding this notice, contact Customer Technical Support: -From our website: http://www.beckmancoulter.com -By phone: call 800 677-7226 option 1 in the United States. If replacement product is needed: -Complete the attached Replacement Order Form and email to askbeckman@beckman.com or fax to (866) 294-7850 OR -Call Client Services at (800) 526-3821
Details
- Recall number
- Z-1609-2026
- Initiated
- July 24, 2025
- Posted by FDA
- March 20, 2026
- Product code
- LTT – Panels, Test, Susceptibility, Antimicrobial
- Quantity
- 685 boxes
- Distribution
- U.S. Nationwide distribution in the states of CA, CO, IN, MA, MD, MN, MO, NC, NJ, OK, PA, and TX.
- Recalling firm
- Beckman Coulter, Inc., West Sacramento, CA