—#209901

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.

FDA product code: DEW — Igg, Antigen, Antiserum, Control
Device class: Class 2
Medical specialty: Immunology
510(k) numbers: K963868
Affected lot / code info: Catalog Number: 447610 UDI-DI code: 15099590221195 Lot Numbers: M307362 M309410

Why it was recalled

Firm identified two lots of reagents that are not meeting the sensitivity statement in the IFU

Root cause (FDA determination)

Employee error

Action the firm took

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.

Recalling firm

Firm: Beckman Coulter Inc.
Address: 250 S Kraemer Blvd, Brea, California 92821-6232

Distribution

Distribution pattern: 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,

Timeline

Recall initiated: 2024-07-31
Posted by FDA: 2024-10-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #209901. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.