MicroScan Neg MIC 56 REF C42464 UDI-DI code: 15099590731212 MicroScan panels are designed for use in determining antimic
FDA device recall Z-1609-2026 · posted 2026-03-20 · Open, Classified
Recall details
- Recalling firm
- Beckman Coulter, Inc.
- Reason for recall
- Due to the likely presence of contamination in well(s).
- 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
- Root cause
- Material/Component Contamination
- Status
- Open, Classified
- Product code
- LTT
- Quantity affected
- 685 boxes
- Distribution
- U.S. Nationwide distribution in the states of CA, CO, IN, MA, MD, MN, MO, NC, NJ, OK, PA, and TX.
- Date initiated
- 2025-07-24
- Date posted
- 2026-03-20
- Location
- West Sacramento, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µg/mL ) (K202343) | Beckman Coulter, Inc. | 2020-11-16 |