Reported May 6, 2015 · Terminated
MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting…
Beckman Coulter, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Beckman Coulter, Inc. · 2040 Enterprise Blvd · West Sacramento, CA · 95691-3427
Is this the product you have?
- MicroScan Microbiology SystemsDried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting
- CLSI M100-S20 Breakpoints PanelES¿L plus
- Catalog B1027-101 MicrobiologyFor 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
- Lot codes and dates
- Catalog numberB1027-101
- Siemens Material Number (SMN)10444755
- Amount recalled
- Approx ~(216240 boxes U.S. and 84249 boxes OUS) total
This recall covers 9 products
The agency filed one notice per product. You are reading one of them; the other 8 are below.
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
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