Recall Z-1772-2026 ยท LTT Panels, Test, Susceptibility, Antimicrobial
Beckman Coulter, Inc.
MicroScan Neg MIC 3J REF C54814
| Date | Apr 3, 2026 (initiated Jun 25, 2025) |
| Status | Open, Classified |
| Reason | Due to a manufacturing issue - missing a drug in well 4/4 but contain double the amount of antibiotics |
| Root cause | Process control |
| Action | On 07/15/2024, firm sent via mail/email an "URGENT MEDICAL DEVICE RECALL" Letter to customer inform them that customers have reported multiple patient samples with skipped wells for Ceftolozane/Tazobactam (C/T) when tested with MicroScan Neg MIC 3J Lot 2025-08-23. The C/T 2/4 dilution well exhibited no growth while growth was observed in the C/T 4/4 well. Customers are instructed to: "Discontinue use of this lot and discard per your laboratory guidelines. "Consider reviewing the C/T antimicrobial susceptibility test results from this lot if Enterobacterales reported as resistant and P. aerugi |
| Quantity | 688 boxes (20 panels per box) |
| Distribution | International distribution in the country of Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.