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IMMAGE recallZ-0118-2025 · Beckman Coulter Inc. · initiated Jul 31, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Beckman Coulter Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Employee error

What the company is doing

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 [email protected] 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.

Recall details

Recall number
Z-0118-2025
Status
Open, Classified
Initiated by the company
Jul 31, 2024
Posted by the FDA
Oct 17, 2024
Recalling firm
Beckman Coulter Inc.
Quantity
12,102 reagents
Product code
DEW
FDA submissions
K963868
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,

Product description

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.

Code information (models, lots, serial numbers)

Catalog Number: 447610 UDI-DI code: 15099590221195 Lot Numbers: M307362 M309410

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

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