Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall 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 Breakpoi

U.S. FDA — Device Enforcement · United States · 2014-08-08 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1529-2015
Date of alert: 2014-08-08
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Beckman Coulter, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 10483099

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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