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U.S. Department of Health and Human Services

Class 2 Device Recall MicroScan Neg MIC 3J

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 Class 2 Device Recall MicroScan Neg MIC 3Jsee related information
Date Initiated by FirmJune 25, 2025
Date PostedApril 03, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1772-2026
Recall Event ID 98553
Product Classification Panels, test, susceptibility, antimicrobial - Product Code LTT
ProductMicroScan Neg MIC 3J REF C54814
Code Information Catalog Number: C54814 UDI code: N/A Lot Number: 2025-08-23
FEI Number 2919016
Recalling Firm/
Manufacturer		 Beckman Coulter, Inc.
2040 Enterprise Blvd
West Sacramento CA 95691-3427
For Additional Information ContactKurtis Montegna
530-990-3496
Manufacturer Reason
for Recall		Due to a manufacturing issue - missing a drug in well 4/4 but contain double the amount of antibiotics
FDA Determined
Cause 2		Process control
ActionOn 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. aeruginosa reported as intermediate or if an increasing trend in resistance has been observed for C/T in your laboratory. "The laboratory should retain the inventory of other MicroScan Neg MIC 3J lots as they are not impacted by this issue. any questions regarding this notice, please contact us: "From our website: http://www.beckmancoulter.com "By phone: please contact: Customer call center TEL :0120-566-730
Quantity in Commerce688 boxes (20 panels per box)
DistributionInternational distribution in the country of Japan.
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.
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