The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1930-2016·Announced 2016-06-15

Beckman Coulter Lipase Reagent Recalled for Potential False Low Results

Beckman Coulter is recalling Lipase OSR6x30 reagent because Dipyrone may cause erroneous false low results in lipase assays.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 erroneous test results (false lows) rather than direct physical injury or death, fitting the criteria for moderate severity where the risk is primarily diagnostic error.

Plain-English summary

Beckman Coulter Inc. is recalling Lipase, Catalog No. OSR6x30, a system reagent intended for the quantitative determination of Lipase activity in human serum on Beckman Coulter AU analyzers. The recall involves 32,926 units total, with 6,041 units distributed in the United States.

The recall was initiated because Beckman Coulter identified that Dipyrone (Metamizole) may cause erroneous, false low results in the Lipase OSR6X30 assay. This issue is part of a broader identification affecting several other assays, including Cholesterol, Triglyceride, Uric Acid, and Lactate, but this specific recall notice pertains to the Lipase reagent.

The product was distributed worldwide, including the United States, Puerto Rico, and numerous international countries. All lots are affected. Healthcare facilities and laboratories using this reagent should stop using the product and contact Beckman Coulter for instructions on return or replacement.

The recalled product

Product
Lipase, Catalog No. OSR6x30 Product Usage: Lipase OSR6x30 is intended as a System reagent for the quantitative determination of Lipase activity in human serum on Beckman Coulter AU analyzers.
Manufacturer
Beckman Coulter Inc.
Category
Medical Device — In Vitro Diagnostic 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 →

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