Recall Z-0118-2025 ยท DEW Igg, Antigen, Antiserum, Control
Beckman Coulter Inc.
IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent REF 447610 IGM reagent, when used in conjunction with IMMAGE Immunochemistry Systems and Calibrator 1, is intended for the quantitative determination of immunoglobulin M (IGM) in human serum by rate nephelometry.
| Date | Oct 17, 2024 (initiated Jul 31, 2024) |
| Status | Open, Classified |
| Reason | Firm identified two lots of reagents that are not meeting the sensitivity statement in the IFU |
| Root cause | Employee error |
| Action | During the week of 08/15/2024, the firm an "URGENT MEDICAL DEVICE RECALL" Letter via first class mail and/or email. The letter informed customer that Beckman Coulter discovered that IMMAGE Immunochemistry Systems IGM Immunoglobulin M reagent lots are not meeting the sensitivity statement in the IFU: Sensitivity is defined as the lowest measurable concentration which can be distinguished from zero with 95% confidence. Sensitivity for IGM determination is 4.2 mg/dL. . Customers are instructed to: -Discontinue use of affected IMMAGE Immunochemistry Systems IGM Immunoglobulin M reagent lots and |
| Quantity | 12,102 reagents |
| Distribution | U.S.: AZ, CA, CO, FL, GA, HI, IL, MA, MI, MO, ND, NY, OH, PA, and TX O.U.S.: Australia, Belgium, Brazil, Chile, China, Czechia, Ecuador, France, Germany, Greece, Hong Kong, India, Italy, Kuwait, Mexico, Philippines, Poland, Portugal, Saudi Arabia, Slovakia, Spain, Sweden, Taiwan Province of China |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K963868 | IMMAGE IMMUNOCHEMISTRY SYSTEM IMMUNOGLOBULIN G (IGG), A (IGA) AND M (IGM) Beckman Instruments, Inc., Feb 10, 1997 |