The Recall Desk
ModerateFDA (Devices)·Z-1931-2016·Announced 2016-06-15

Beckman Coulter Lactate Reagent Recalled for Potential False Low Results

Beckman Coulter is recalling Lactate OSR6x93 reagent because Dipyrone may cause erroneous false 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, but the hazard involves erroneous test results rather than direct physical injury or contamination, fitting the criteria for moderate severity.

Plain-English summary

Beckman Coulter Inc. is recalling Lactate, Catalog No. OSR6x93, a system reagent intended for the quantitative determination of L-Lactate in human plasma and cerebrospinal fluid (CSF) on Beckman Coulter AU analyzers. The recall affects all lots of the product.

The recall was initiated because Beckman Coulter identified that Dipyrone (Metamizole) may cause erroneous, false low results in the Lactate OSR6X93 assay. This issue may also affect other assays, including Cholesterol OSR6X16, Triglyceride OSR6X118, Uric Acid OSR6X98, and Lipase OSR6X30.

A total of 54,351 units were distributed worldwide, with 31,612 units distributed in the United States, including Puerto Rico. The product was distributed to numerous countries globally. Users should stop using the affected reagent and contact Beckman Coulter for further instructions.

The recalled product

Product
Lactate, Catalog No. OSR6x93 Product Usage: Lactate OSR6x93 is intended as a System reagent for the quantitative determination of L-Lactate in human plasma and cerebrospinal fluid (CSF) on Beckman Coulter AU analyzers.
Manufacturer
Beckman Coulter Inc.
Category
Medical Device — Laboratory Reagent
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 1 state specifically:

Part of a larger recall action

This product is one of 5 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 5 products in this recall →

Related recalls

Same manufacturer · Beckman Coulter Inc.

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Same hazard · erroneous results

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