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Recall Observatory FDA recall evidence

Device product

MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg/Urine Combo 55, Catalog B1017-409 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.

Z-1531-2015

August 08, 2014

Class II

Product summary

Firm
Beckman Coulter, Inc.
Event
Event 70893
Status
Terminated
Classification
Class II
Quantity
Approx ~(216240 boxes U.S. and 84249 boxes OUS) total
Official record key
device-enforcement:Z-1531-2015

Official wording

Reason: 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.

Code information: Catalog number: B1017-409; Siemens Material Number (SMN): 10371533.

Distribution pattern: 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 Emirates, Uruguay, and Venezuela.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.