IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent REF 447610 IGM reagent, when used in conjunction with IMMAGE

FDA device recall Z-0118-2025 · posted 2024-10-17 · Open, Classified

Recall details

Recalling firm

Beckman Coulter Inc.

Reason for recall

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

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.

Root cause

Employee error

Status

Open, Classified

Product code

DEW

Quantity affected

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, Mexic

Date initiated

2024-07-31

Date posted

2024-10-17

Location

Brea, CA

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