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

Recall Z-0989-2013 — VITEK 2 60 computer system when equipped with the following Hewlett-Packard PC models: (1) rp5700, Cat. #W0452; (2) rp5700 (refurbished), Cat. #W0452R; (3) rp5800 XPE, Cat. 413642; (4) rp5800 WES7, Cat. #413862; (5) dc7100 8-port, Cat. #W0441; (6) dc7100 8-port (refurbished), Cat. #W0441R;

U.S. FDA — Device Enforcement · United States · 2013-02-18 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0989-2013
Date of alert: 2013-02-18
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Biomerieux Inc
Product category: device
Product type: Devices

Reported risk: There is a potential to link an isolate result to the wrong patient and then upload the results to the LIS.

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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