Enforcement Report - Week of October 10, 2012
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Product Detail
| Product Description | 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. |
|---|---|
| Recall Number | Z-0003-2013 |
| Classification | Class II |
| Code Info | Lot# M012376 and M101865 |
| Product Distributed Qty | 925 units |
| 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. |
Event Detail
| Event Id | 63152 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Beckman Coulter Inc. |
| City | Brea |
| State | CA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-01-27 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Worldwide distribution: USA (nationwide) and country of: Canada. |
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