Recall archive / FDA device enforcement
Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry — FDA record Z-1003-2024
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 Dec 15, 2023. 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
- Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
- Reason
- Potential for a negative bias with quality control (QC) and patient sample results when using the Atellica CH Immunoglobulin M_2 (IgM_2) reagent.
- Classification
- Class II
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 7,075 units (927 US, 6148 OUS)
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1003-2024
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 | Siemens Material Number (SMN): 11097620; UDI DI: 00630414595627; Lot No. (Exp. Date): 221764 (10/01/2023), 221829 (02/01/2024), 231915 (06/01/2024), 232025 (11/01/2024). |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, and PR; The countries of Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, Colombia, Croatia, Curacao, Czech Republic, Denmark, Egypt, Estonia, Finland France, Germany, Greece, Hong Kong, Hungary, India, Iran, Ireland, Israel, Italy, Ivory Coast, Japan, Jordan, Kenya, Kuwait, Latvia, Macedonia, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, P.R. China, Pakistan, Paraguay, Peru, Poland, Portugal, Republic South Korea, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, U.A.E, United Kingdom, Uruguay, Vatican City, Vietnam, Zaire.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Feb 14, 2024
- Recall initiation date
- Dec 15, 2023
- Center classification date
- Feb 7, 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.