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

Recall Z-0588-2017 — Alere Triage Total 5 Control Level 1, Model No. 88753 Description of the product: The Triage Total Controls 5 are quality control materials that are used to assist the laboratory in monitoring test performance throughout the measurable range. They are not calibrators and are not used to calibrate

U.S. FDA — Device Enforcement · United States · 2016-10-12 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0588-2017
Date of alert: 2016-10-12
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Alere San Diego, Inc.
Product category: device
Product type: Devices

Reported risk: Encoded with incorrect ranges that are not consistent with the ranges printed on the Expected Value Card.

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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