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

Recall Z-1990-2019 — Immunoglobulin M is an in vitro diagnostic assay for the quantitative determination of immunoglobulin M in human serum or plasma. Antigen in the sample bonds to the specific antibody in the reagent, forming an immune complex. The immune complex causes an increase in light scattering, measured by

U.S. FDA — Device Enforcement · United States · 2018-05-16 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1990-2019
Date of alert: 2018-05-16
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Abbott Laboratories, Inc
Product category: device
Product type: Devices

Reported risk: An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the various products.

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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