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

Recall Z-1148-2013 — IMO-402 Mononucleosis Rapid Test Device (Whole Blood/Serum/Plasma). Catalog #IMO-402/94201 The MONO test (Whole Blood) is a rapid chromatographic immunoassay for the qualitative detection of Infectious Mononucleosis heterophile antibodies in whole blood to aid in the diagnosis of infectious Mono

U.S. FDA — Device Enforcement · United States · 2013-02-26 · Class III

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1148-2013
Date of alert: 2013-02-26
Country / jurisdiction: United States
Risk level: Class III
Risk type: recall
Brand: Alere San Diego, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 11030386

Reported risk: Alere San Diego is recalling the Clearview Mononucleosis Cassette because the positive control included in the rapid test may produce false negative results.

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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