Beckman Coulter Clinical Reagent Recalled Due to Incorrect Lipemia Check Settings
Beckman Coulter has recalled 13,565 units of IGM clinical reagent due to incorrect lipemia check settings that may produce false low results or report high results as normal. Affected units were distributed worldwide.
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 medical device recall with diagnostic accuracy risk from incorrect lipemia settings potentially causing false results. No illnesses or injuries reported, limiting severity to High per rubric guidance that risk-of-harm products without reported injury cannot exceed this level.
Plain-English summary
Beckman Coulter Inc. has recalled 13,565 units of its IGM clinical reagent (REF: OSR61173) due to incorrect lipemia influence check settings. The incorrect settings may cause laboratory test results to be reported as false lows or may result in high results being reported as normal, affecting the accuracy of patient test results.
The affected reagent units were distributed worldwide, including throughout the United States and more than 50 countries. The recall includes multiple lot numbers (2548 through 2554) with expiration dates ranging from June 2024 through March 2026.
Healthcare facilities using the affected reagent should contact Beckman Coulter for guidance on remediation, product replacement, or procedures for addressing potentially affected test results.
The recalled product
- Product
- Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2
- Manufacturer
- Beckman Coulter Inc.
- Affected units
- 13,565
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 (7)
- UDI: 15099590011598/ All Lots: 2548/Exp. 2024-06-01
- 2549/Exp.2024-10-01
- 2550/Exp. 2024-11-01
- 2551/Exp. 2025-04-01
- 2552/Exp. 2025-07-01
- 2553/Exp. 2025-10-01
- 2554/ Exp. 2026-03-01
Distribution
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