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[Recalled] Beckman Coulter, Uric Acid Assay, Catalog No. OSR6X98 — N-Acetyl Cysteine (NAC), when administered in therapeutic concentrations for th… | FDA 2014-12-15

recall fda device united-states

Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.

Recall details

ProductBeckman Coulter, Uric Acid Assay, Catalog No. OSR6X98
Brand / manufacturerBeckman Coulter Inc.
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-1024-2015
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date15 December 2014

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: N-Acetyl Cysteine (NAC), when administered in therapeutic concentrations for the treatment of acetaminophen overdose, interferes with the assays for these analytes: Cholesterol OSR6X16, Uric Acid OSR6X98, Lactate OSR6X93, and Lipase OSR6X30. NAC interference may lead to falsely low results.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Beckman Coulter Inc.

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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