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

Recall Z-2268-2016 — Henry Schein One Step + Mono Rapid Test Device, Catalog No. 9004070 a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.

U.S. FDA — Device Enforcement · United States · 2016-06-22 · Class III

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2268-2016
Date of alert: 2016-06-22
Country / jurisdiction: United States
Risk level: Class III
Risk type: recall
Brand: Alere San Diego, Inc.
Product category: device
Product type: Devices

Reported risk: The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.

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.

Recall Z-2268-2016 — Henry Schein One Step + Mono Rapid Test Device, Catalog No. 9004070 a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.

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