Beckman Coulter, Inc. recalls MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting…

Recall date

August 8, 2014

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1532-2015

FDA classification

Class II

Brand / firm

Beckman Coulter, Inc.

Sold / distributed

Worldwide Distribution: US (Nationwide) and to countries of: Argentina, Bahamas, Brazil, Canada, China, Ecuador, Egypt, Germany, Lithuania, Mexico, Paraguay, Peru Poland, Portugal, Romania, Russian Federation, Singapore, South Africa, Spain, Taiwan, Thailand, Trinidad and Tobago, United Arab Emirat…

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg/Urine Combo 61, Catalog B1017-414 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.