Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Recalled by Beckman Coulter, Inc. Due to Technical Support Bulletin issued in February 2013 did...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Beckman Coulter, Inc. directly.
Affected Products
MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg/Urine Combo 51, Catalog B1017-407 Microbiology: 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 bacilli.
Quantity: Approx ~(216240 boxes U.S. and 84249 boxes OUS) total
Why Was This Recalled?
Technical Support Bulletin issued in February 2013 did not mention performance limitation for Proteus mirabilis and Imp when using the CLSIM100-S20 revised interpretive criteria.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Beckman Coulter, Inc.
Beckman Coulter, Inc. has 79 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report