Recall Z-0003-2013 ยท DHR System, Test, Rheumatoid Factor
Beckman Coulter Inc.
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 Syst
| Date | Oct 1, 2012 (initiated Jan 27, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | The firm, Beckman Coulter, sent an "URGENT PRODUCT CORRECTION" letter dated January 27, 2012 with an attached PCA Response Form to all customers who purchased the IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) Reagent. The letter describes the product, problem and actions to be taken. The customers were instructed to discontinue use of IMMAGE RF reagent lots M012376 and M101865; call Order Assistance at (800) 526-3821 in the United States, (800) 463-7828 in Canada or contact your local Beckman Coulter representative for replacements; and complete and return the enclosed FAX BACK RESPON |
| Quantity | 925 units |
| Distribution | Worldwide distribution: USA (nationwide) and country of: Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K963048 | IMMAGE SYSTEM RHEUMATOID FACTOR (RF) REAGENT Beckman Instruments, Inc., Nov 4, 1996 |