Beckman Coulter Inc.: Medical Device Recall in 2012 - (Recall #: Z-0003-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: January 27, 2012

Date Posted: October 10, 2012

Recall Number: Z-0003-2013

Event ID: 63152

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.

Status: Terminated

Product Quantity: 925 units

Code Information:

Lot# M012376 and M101865

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated