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

Recall Z-1529-2018 — Accelerate PhenoTest BC kit, Ref #10101018. The firm name on the label is Accelerate Diagnostics, Tucson, AZ. A multiplexed in-vitro diagnostic test intended for use with the Accelerate Pheno system.

U.S. FDA — Device Enforcement · United States · 2018-03-14 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1529-2018
Date of alert: 2018-03-14
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Accelerate Diagnostics Inc
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 10101018

Reported risk: The kits may produce an elevated rate of false positive calls for the Staphylococcus aureus identification probe (SAU).

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.

Recall Z-1529-2018 — Accelerate PhenoTest BC kit, Ref #10101018. The firm name on the label is Accelerate Diagnostics, Tucson, AZ. A multiplexed in-vitro diagnostic test intended for use with the Accelerate Pheno system.

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