FDAFDA · Food and drugs·Recall number Z-0003-2013
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.
Published October 10, 2012 · Recall initiated: January 27, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Beckman Coulter Inc.
- Distributor
- Worldwide distribution: USA (nationwide) and country of: Canada.
- Lot
- Lot# M012376 and M101865
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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