Recall Z-1609-2026 · LTT Panels, Test, Susceptibility, Antimicrobial
Beckman Coulter, Inc.
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.
| Date | Mar 20, 2026 (initiated Jul 24, 2025) |
| Status | Open, Classified |
| Reason | Due to the likely presence of contamination in well(s). |
| Root cause | Material/Component Contamination |
| Action | 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 detect |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K202343 | MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µg/mL ) Beckman Coulter, Inc., Nov 16, 2020 |