IMMAGE Immunochemistry Systems Rheumatoid Factor — Class II medical device recall Z-0003-2013
Terminated recall by Beckman Coulter Inc., reported 2012-10-10, distributed nationwide. The recall was initiated because Beckman Coulter has confirmed customer reports of QC shifts, lot-to-lot varia
| Recall number | Z-0003-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2012-01-27 |
| Classified | 2012-10-01 |
| Reported by FDA | 2012-10-10 |
| Terminated | 2013-05-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 925 units |
| Lot numbers | M012376, M101865 |
Product
IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) Reagent, PN 447070 The IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) reagent, in conjunction with Beckman Cal 5 Plus, is intended for use in the quantitative determination of human rheumatoid factor concentrations in human serum and plasma samples by rate nephelometry. This assay is designed for use with the IMMAGE Immunochemistry System.
Reason for recall
The recall was initiated because Beckman Coulter has confirmed customer reports of QC shifts, lot-to-lot variation, and an increase in the percent of patient samples recovering >20 IU/mL using the Lots# M012376 and M101865 of IMMAGE RF reagent. The lots identified for the RF reagent might produce false abnormal results.
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-0003-2013. 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.