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.
FDA Recall Z-1609-2026 · Posted 2026-03-20
Recalling FirmBeckman Coulter, Inc.
Recall StatusOpen, Classified
Product CodeLTT
Date Initiated2025-07-24
Product Quantity685 boxes
Reason for Recall
Due to the likely presence of contamination in well(s).
Firm 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 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 [email protected] or fax to (866) 294-7850 OR
-Call Client Services at (800) 526-3821
Root Cause
Material/Component Contamination
Distribution Pattern
U.S. Nationwide distribution in the states of CA, CO, IN, MA, MD, MN, MO, NC, NJ, OK, PA, and TX.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.