The Recall Desk
HighFDA (Devices)·Z-0210-2020·Announced 2019-10-30

Beckman Coulter Lipase Recalled Due to Acetaminophen Interference

Beckman Coulter is recalling Lipase assays because acetaminophen metabolites cause negative interference in overdose patients.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (medical device) where the hazard is negative interference in assays for overdose patients, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Beckman Coulter Inc. is recalling Beckman Coulter Lipase, REF OSR6130 and OSR6230. The recall involves 20,926 units distributed nationwide, including to government and military entities, as well as to Canada.

The recall is due to negative interference with the product assays caused by NAPQI, a metabolite of acetaminophen. This interference occurs at levels present in the serum or plasma of overdose patients.

Healthcare providers and laboratories should stop using the affected units and contact Beckman Coulter for instructions on return or replacement.

The recalled product

Product
Beckman Coulter Lipase, REF OSR6130 and OSR6230.
Manufacturer
Beckman Coulter Inc.
Category
Medical Device — Laboratory Reagents
Hazard
Affected units
20,926

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.

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

Related recalls

Same manufacturer · Beckman Coulter Inc.

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Same hazard · assay interference

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