The Recall Desk
ModerateFDA (Devices)·Z-1023-2015·Announced 2015-02-04

Beckman Coulter Lipase Assay Recalled Due to NAC Interference

Beckman Coulter is recalling Lipase Assay kits because N-acetyl cysteine can cause falsely low results.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves potential diagnostic errors (falsely low results) due to drug interference, which fits the criteria for moderate severity without reported injuries.

Plain-English summary

Beckman Coulter Inc. is recalling the Lipase Assay, Catalog No. OSR6X30. The recall affects 75,959 units total, with 31,233 units distributed in the United States and Puerto Rico. The product was distributed worldwide to numerous countries.

The recall is due to interference from N-acetyl cysteine (NAC). When NAC is administered in therapeutic concentrations for the treatment of acetaminophen overdose, it interferes with the assay. This interference may lead to falsely low results for lipase.

The recalled product

Product
Beckman Coulter, Lipase Assay, Catalog No. OSR6X30
Manufacturer
Beckman Coulter Inc.
Category
Medical Device — Laboratory Assay
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All Lots

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 4 recalled by Beckman Coulter Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Related recalls

Same manufacturer · Beckman Coulter Inc.

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Same hazard · diagnostic error

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