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.
- Company
- Beckman Coulter Inc.
- Recall Initiated
- July 31, 2024
- Posted
- October 17, 2024
- Recall Number
- Z-0118-2025
- Quantity
- 12,102 reagents
- Firm Location
- Brea, CA
Reason for Recall
Firm identified two lots of reagents that are not meeting the sensitivity statement in the IFU
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, and Turkey,
Lot / Code Info
Catalog Number: 447610 UDI-DI code: 15099590221195 Lot Numbers: M307362 M309410
Root Cause
Employee error
Action Taken
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 to follow product replacement instructions. -Review the Safety Data Sheet (SDS) and discard according to their laboratory's Standard Operating Procedures and/or their local regulations. SDS is available on www.beckmancoulter.com -Share the content of Recall Letter with their lab and/or medical director regarding the need to perform a retrospective review of patient results. Beckman Coulter is no longer distributing the affected lots. For questions, contact Customer Support Center: . From website: http://www.beckmancoulter.com . By phone: call 1-800-854-3633 in the United States. o Outside the United States, contact local Beckman Coulter representative. . For customers in the United States, if need replacement product: o Complete the attached Replacement Order Form and email to askbeckman@beckman.com or fax to (866) 294-7850 OR o Call Client Services at (800) 526-3821 . For customers in other geographies, contact local Beckman Coulter Representative for replacement.