MicroScan recallZ-1609-2026 · Beckman Coulter, Inc. · initiated Jul 24, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Beckman Coulter, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Due to the likely presence of contamination in well(s).
FDA root cause category: Material/Component Contamination
What the company is doing
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
Recall details
- Recall number
- Z-1609-2026
- Status
- Open, Classified
- Initiated by the company
- Jul 24, 2025
- Posted by the FDA
- Mar 20, 2026
- Recalling firm
- Beckman Coulter, Inc.
- Quantity
- 685 boxes
- Product code
- LTT
- FDA submissions
- K202343
- Distribution
- U.S. Nationwide distribution in the states of CA, CO, IN, MA, MD, MN, MO, NC, NJ, OK, PA, and TX.
Product description
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.
Code information (models, lots, serial numbers)
Catalog Number: C42464 UDI-DI code: 15099590731212 Lot Number: 2026-01-03
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- MicroScan C42464Beckman Coulter, Inc. · Susceptibility Test Cards, Antimicrobial1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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