Medical Device Reagent Recalled for Unreliable Test Results
Beckman Coulter's Transferrin reagent lot 2573 does not maintain stability as claimed, causing unreliable patient test results and control failures. The company confirmed the issue affects diagnostic accuracy.
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 diagnostic reagent recall with 2 documented safety cases and 99 quality cases. While no specific patient illnesses or injuries are reported in the source, the confirmed failure to meet stability claims creates a significant risk of erroneous test results, which could affect patient care and clinical decision-making.
Plain-English summary
Beckman Coulter Biomedical Division is recalling 2,754 units of the AU/DxC AU Chemistry Transferrin reagent (REF: OSR6152, lot 2573, expiration August 1, 2024) due to stability issues affecting diagnostic test results.
The reagent fails to meet the on-board stability claims specified in the product instructions for use. Internal testing by Beckman Coulter on June 30, 2023 confirmed the issue. The company has documented 2 safety cases and 99 quality cases where the affected reagent caused reagent blank shifts, imprecision, calibration failures, erratic quality control recoveries, and erroneous results for serum, plasma, and urine patient samples.
The affected reagent was distributed worldwide to the United States (all 50 states plus Guam and Puerto Rico) and to more than 30 countries spanning North America, Europe, Asia, Africa, and Oceania.
The recalled product
- Product
- AU/DxC AU Chemistry Transferrin REF: OSR6152 Immune complexes formed in solution scatter light in proportion to their size, shape and concentration. Turbidimeters measure the reduction of incident light due to reflection, absorption, or scatter. In the procedure, the…
- Manufacturer
- Beckman Coulter Biomedical Division
- Affected units
- 2,754
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 (3)
- UDI-DI: 15099590010492
- LOT: 2573
- Expiration: 01 August 2024
Distribution
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