Beckman Coulter Bicarbonate Reagent Recalled for Potential Calibration Failures
Beckman Coulter has recalled Bicarbonate reagent used in laboratory testing due to a potential decrease in calibration readings. The issue could result in calibration and quality control failures.
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 3/5 (High).
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: This is an FDA Class II recall of a laboratory reagent with a potential calibration issue. No illnesses, injuries, or deaths are reported in the source. The hazard is theoretical—a potential decrease in calibration optical densities that could cause failures in laboratory testing. Per the rubric, risks without reported harm score at most 3.
Plain-English summary
Beckman Coulter Inc. is recalling Bicarbonate reagent (REF: OSR6237, 4x50 mL). A total of 48,633 units were distributed worldwide, including throughout the United States and to Brazil, Canada, Mexico, Panama, and Taiwan.
The recall was issued due to a potential decrease in calibration optical densities of the reagent. This issue could result in calibration failures and quality control failures.
The affected product is identified by UDI-GI: 15099590010348. Healthcare facilities and laboratories using this reagent should contact Beckman Coulter Inc. regarding this recall (FDA recall number Z-1607-2023).
The recalled product
- Product
- Beckman Coulter Bicarbonate, REF: OSR6237, 4x50 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: 15099590010348
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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