Recall archive / FDA device enforcement
IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent REF 447610 IGM reagent, when used in conjunction with IMM... — FDA record Z-0118-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jul 31, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Reason
- Firm identified two lots of reagents that are not meeting the sensitivity statement in the IFU
- Classification
- Class II
- Recalling firm
- Beckman Coulter Inc.
- Quantity
- 12,102 reagents
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0118-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Catalog Number: 447610 UDI-DI code: 15099590221195 Lot Numbers: M307362 M309410 |
Match all identifying details in the current notice. A brand name alone is not enough.
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,
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Oct 23, 2024
- Recall initiation date
- Jul 31, 2024
- Center classification date
- Oct 17, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.