FDA Medical Device Recalls (openFDA)
Beckman Coulter, Inc.: MicroScan Neg MIC 3J REF C54814
- Recall number
- Z-1772-2026
- Recalling firm
- Beckman Coulter, Inc.
- Product
- MicroScan Neg MIC 3J REF C54814
- Status
- Open, Classified
- Initiated
- 2025-06-25
- Posted
- 2026-04-03
- Terminated
- not on file
- Reason
- Due to a manufacturing issue - missing a drug in well 4/4 but contain double the amount of antibiotics
- Root cause
- Process control
- Action
- On 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
- 688 boxes (20 panels per box)
- Distribution
- International distribution in the country of Japan.
- Lot, serial or model codes
- Catalog Number: C54814 UDI code: N/A Lot Number: 2025-08-23
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LTT
- Firm FEI
- 2919016
- Firm city
- West Sacramento
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28