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U.S. Department of Health and Human Services

Class 2 Device Recall MicroScan Neg MIC 56

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 Class 2 Device Recall MicroScan Neg MIC 56see related information
Date Initiated by FirmJuly 24, 2025
Date PostedMarch 20, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1609-2026
Recall Event ID 98555
510(K)NumberK202343 
Product Classification Panels, test, susceptibility, antimicrobial - Product Code LTT
ProductMicroScan 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 Catalog Number: C42464 UDI-DI code: 15099590731212 Lot Number: 2026-01-03
FEI Number 2919016
Recalling Firm/
Manufacturer		 Beckman Coulter, Inc.
2040 Enterprise Blvd
West Sacramento CA 95691-3427
For Additional Information Contact
530-990-4396
Manufacturer Reason
for Recall		Due to the likely presence of contamination in well(s).
FDA Determined
Cause 2		Material/Component Contamination
ActionOn 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
Quantity in Commerce685 boxes
DistributionU.S. Nationwide distribution in the states of CA, CO, IN, MA, MD, MN, MO, NC, NJ, OK, PA, and TX.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = LTT
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