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

Recall Z-1921-2013 — bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit V2S RP5800XPE TO 6.01 WES7. Part number: 6201773. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification

U.S. FDA — Device Enforcement · United States · 2013-06-14 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1921-2013
Date of alert: 2013-06-14
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Biomerieux Inc
Product category: device
Product type: Devices

Reported risk: A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx to 6.01, the Bid-directional Computer interface (BCI) antibiotic codes are not updated properly for Cefovecin, Prulifloxacin and Ceftaroline. For the referenced antibiotics, the firm code in the reference table

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

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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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