Recall Z-0003-2013— Beckman Coulter Inc.

Name: FDA recall Z-0003-2013
Creator: U.S. Food and Drug Administration
Published: 2012-01-27

Class II · Terminated

Class II FDA medical device recall by Beckman Coulter Inc., initiated 2012-01-27, terminated 2013-05-30. It names one FDA 510(k) clearance: K963048. 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: 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..

Recalling firm: Beckman Coulter Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-01-27
Terminated: 2013-05-30
Firm location: Brea, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K963048 — IMMAGE SYSTEM RHEUMATOID FACTOR (RF) REAGENTBeckman Instruments, Inc.·cleared 1996-11-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.