Beckman Coulter, Inc. recalls MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Inte…
Reason for recall
Due to manufacturing issue (incorrectly processing) with in vitro multidrug resistant test.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended Use- For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. 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 bacilliUDI-DI codeCatalog # NumberAffected lot2026-05-08
What the firm is doing
On 09/08/2025, the firm sent via mail/email an "URGENT FIELD SAFETY NOTICE" to customers informing them that as a result of an internal investigation Beckman Coulter confirmed that Ciprofloxacin (Cp) antimicrobial agent was incorrectly manufactured on MicroScan Neg Multidrug Resistant MIC 1 Lot 2026-05-08. Customers are instructed to: "Review Ciprofloxacin results generated from Lot 2026-05-08 to identify any abnormal or unexpected trends in both susceptible and resistance patterns, or unexpected change in MIC trends, as compared to historical results for that same species (e.g. a sudden, unexplained increase in susceptible or % susceptible results for a species after implementation of Lot 2026-05-08 versus the previous susceptible or % susceptible results for the same species prior to using Lot 2026-05-08). "Discontinue use of this lot and discard per your laboratory guidelines "The laboratory should retain the inventory of other MicroScan Neg Multidrug Resistant MIC 1 lots as they are not impacted by this issue. Note-Beckman Coulter is no longer distributing MicroScan Neg Multidrug Resistant MIC 1 Lot 2026-05-08 For questions - contact Customer Support Center from website: http://www.beckmancoulter.com
DistributionShow detailsHide
International distribution to the country of Poland.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-1794-2026
- FDA device classification · LTTOfficial FDA classification for this device type
- CFR regulation · 21 CFR 866.1640The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Beckman Coulter, Inc.Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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