Apo B Reagent, REF: OSR6143
Reported: June 4, 2025 Initiated: April 23, 2025 #Z-1815-2025
Product Description
Apo B Reagent, REF: OSR6143
Reason for Recall
The product Value Assignment Sheet (VAS) is used in calibration of the device. An erroneous value was included in the VAS which has the potential to generate an incorrect APO B patient result which could exceed the total allowable error for the APO B assay (11.6%). The error results in results with a positive bias up to 42%. However, based on the mitigating factors the risk to health is considered to be negligible or limited.
Details
- Recalling Firm
- Beckman Coulter Ireland, Inc.
- Units Affected
- 2747 units
- Distribution
- Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, IL, IN, MD, MI, NJ, NY, OH, OK, OR, PA, TX, VA, WA, WV and the countries of Argentina, Australia, Belarus, Belgium, Bulgaria, Canada, China, Czechia, Egypt, Estonia, France, Germany, Ghana, Greece, Hong Kong, India, Ireland, Israel, Italy, Korea, Republic of, Malaysia, Netherlands, New Zealand, Russian Federation, Saudi Arabia, Slovakia, Spain, Switzerland, Taiwan, Province of China, United Kingdom of Great Britain and Northern Ireland, United States of America, Viet Nam.
- Location
- O'Callaghan'S Mills, N/A
Frequently Asked Questions
What product was recalled? ▼
Apo B Reagent, REF: OSR6143. Recalled by Beckman Coulter Ireland, Inc.. Units affected: 2747 units.
Why was this product recalled? ▼
The product Value Assignment Sheet (VAS) is used in calibration of the device. An erroneous value was included in the VAS which has the potential to generate an incorrect APO B patient result which could exceed the total allowable error for the APO B assay (11.6%). The error results in results with a positive bias up to 42%. However, based on the mitigating factors the risk to health is considered to be negligible or limited.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 4, 2025. Severity: Low. Recall number: Z-1815-2025.
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