IMMAGE IGM Immunoglobulin M Reagent (Beckman Coulter) – Sensitivity Issue (2024)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Beckman Coulter Inc.
Lot Codes / Batch Numbers
Catalog Number: 447610 UDI-DI code: 15099590221195 Lot Numbers: M307362 M309410
Products Sold
Catalog Number: 447610 UDI-DI code: 15099590221195 Lot Numbers: M307362 M309410
Beckman Coulter Inc. is recalling IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent REF 447610 IGM reagent, when used in due to Firm identified two lots of reagents that are not meeting the sensitivity statement in the IFU. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Firm identified two lots of reagents that are not meeting the sensitivity statement in the IFU
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, CA, CO, FL, GA, HI, IL, MA, MI, MO, NY, ND, OH, PA, TX
Page updated: Jan 10, 2026