FDAFDA · Food and drugs·Recall number Z-1529-2015
MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg/BP Combo 47, Catalog B1017-417 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.
Published May 6, 2015 · Recall initiated: August 8, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Beckman Coulter, Inc.
- Distributor
- 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.
- Lot
- Catalog number: B1017-417; Siemens Material Number (SMN): 10483099.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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