The Recall Desk
HighFDA (Devices)·Z-1606-2023·Announced 2023-05-24

Beckman Coulter Bicarbonate Reagent Worldwide Recall Due to Calibration Failure Potential

Beckman Coulter is recalling Bicarbonate reagent (REF: OSR6137) worldwide due to potential decreases in calibration optical densities that could cause calibration and quality control failures in clinical laboratory tests.

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: FDA Class II recall of a clinical laboratory reagent with potential for calibration and quality control failures. No illnesses, injuries, or actual failures have been reported; the risk is theoretical, making this a risk-of-harm product where injury has not yet been reported, which qualifies as severity score 3 per the rubric.

Plain-English summary

Beckman Coulter Inc. is recalling Bicarbonate reagent (REF: OSR6137, 4x25 mL) distributed worldwide. Approximately 48,633 units are affected by this recall.

The reagent has the potential to decrease in optical density (OD) values, which could result in calibration failures and quality control failures. This could impact the accuracy of laboratory test results.

The recalled product was distributed nationally across all U.S. states, U.S. territories (Guam and Puerto Rico), and internationally to Brazil, Canada, Mexico, Panama, and Taiwan.

Laboratories and healthcare facilities using this reagent should discontinue use and contact Beckman Coulter for instructions on product replacement or other corrective measures. No illnesses or injuries have been reported at this time.

The recalled product

Product
Beckman Coulter Bicarbonate, REF: OSR6137, 4x25 mL
Manufacturer
Beckman Coulter Inc.
Category
Medical Device — Clinical Laboratory Reagent
Hazard
Affected units
48,633

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: UDI-GI: 15099590020187

Distribution

Distributed nationwide across the United States.

The notice also names 52 states specifically:

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

Related recalls

Same manufacturer · Beckman Coulter Inc.

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Same hazard · calibration failure

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