FDA-Device2012-10-10Class IIPROCESSING DEFECT

Beckman Coulter IMMAGE Rheumatoid Factor Reagent recalled for false test results

FALSE CLAIMSNationwide distribution

Stop using Beckman Coulter RF reagent lots M012376, M101865

Beckman Coulter is recalling two specific lots of IMMAGE Rheumatoid Factor (RF) reagent used in medical laboratories to measure rheumatoid factor levels in blood samples. These lots may produce incorrect test results, showing abnormally high values when they should be normal or lower.

Check if your laboratory uses IMMAGE RF reagent lots M012376 or M101865
Stop using these specific lots immediately
Contact Beckman Coulter for replacement reagent or instructions
Consider retesting affected patient samples with replacement reagent if clinically indicated

Hazard

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.

Sold states

Worldwide distribution: USA (nationwide) and country of: Canada.

Affected count

925 units

Manufactured in

250 S Kraemer Blvd, N/A, Brea, CA, United States

Products

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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0003-2013

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