AU/DxC AU Chemistry Transferrin REF: OSR6152 Immune complexes formed… — Class II medical device recall Z-0309-2024
Ongoing recall by Beckman Coulter Biomedical Division, reported 2023-11-22, distributed nationwide. The firm has identified that the Transferrin reagent does not meet the Instructions for Use (IFU) reagent on-b
| Recall number | Z-0309-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Biomedical Division, County Clare, N/A, Ireland |
| Recall initiated | 2023-09-06 |
| Classified | 2023-11-16 |
| Reported by FDA | 2023-11-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, BR, CA, CH, CN, CR, CZ, DE, EG, ES, FR, GB, GH, HU, IE, IN, IT, KE, KR, MX, MY, NL, NZ, PA, PL, PT, RO, RU, SE, SG, SK, TH, TN, TR, UY, VN, ZA |
| Quantity | 2,754 |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 15099590010492 |
| Lot numbers | 2573 |
| Model numbers | OSR6152 |
| Expiration dates | 2024-08-01 |
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 measurement of the decrease in light transmitted (increase in absorbance) through particles suspended in solution as a result of complexes formed during the antigen-antibody reaction, is the basis of this assay.
Reason for recall
The firm has identified that the Transferrin reagent does not meet the Instructions for Use (IFU) reagent on-board stability claims, which may cause control failures and/or erroneous patient samples results. The Complaint handling unit has received a total of 2 safety cases (CASE-2023-02027212 and CASE-2023-02045278) and 99 quality cases with the failure mode attributed to Transferrin reagent (OSR6152 / lot 2573) associated with reagent blank shifts for the Reagent 2 (R2), imprecision, calibration failures, erratic Quality Control (QC) recoveries, and/or erroneous high/low (serum, plasma, urine) patient results. The issue was confirmed through internal testing by Beckman Coulter on June 30, 2023. Reagent Blank shifts for R2, imprecision, calibration failures, erratic Quality Control (QC) recoveries, and/or erroneous high/low (serum, plasma, urine) patient results. The issue was confirmed through internal testing by Beckman Coulter on June 30, 2023.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0309-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.