Beckman Coulter Bicarbonate Reagent Recalled for Calibration Failure Risk
Beckman Coulter is recalling Bicarbonate reagent (REF: OS6637) due to potential calibration failures. The reagent could produce decreased optical density readings affecting laboratory quality control.
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: FDA Class II recall with no reported illnesses or injuries. The hazard involves potential calibration failures in a laboratory reagent, which is a technical quality assurance issue rather than a direct patient safety hazard with reported harm.
Plain-English summary
Beckman Coulter Inc. is recalling approximately 48,633 units of Bicarbonate reagent (REF: OS6637, 4x173 mL) distributed worldwide. The recalled product was distributed throughout the United States, Guam, Puerto Rico, and foreign countries including Brazil, Canada, Mexico, Panama, and Taiwan.
The recall was issued due to a potential for a decrease in calibration optical densities (ODs) for the Bicarbonate reagent. This could result in calibration failures and/or quality control failures in clinical laboratories using the product.
Clinical laboratories should evaluate whether they have the recalled reagent (UDI-GI: 15099590060206) and assess the validity of calibrations and quality control results obtained with affected lots. Laboratories should contact Beckman Coulter Inc. for instructions on replacement or corrective actions.
The recalled product
- Product
- Beckman Coulter Bicarbonate, REF: OS6637, 4x173 mL
- Manufacturer
- Beckman Coulter Inc.
- 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: 15099590060206
Distribution
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.
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