CLASS II ONGOING Device recall · Reported 14 Feb 2024 · FDA Enforcement Report
Total immunoglobulin M (IgM total) IVD, kit recalled
Siemens Healthcare Diagnostics is recalling Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry, distributed nationwide in the US. The recall was initiated on 15 Dec 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1003-2024
- FDA event ID
- 93782
- Recalling firm
- Siemens Healthcare Diagnostics, Tarrytown, NY
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 15 Dec 2023
- FDA classified
- 7 Feb 2024
- Reported
- 14 Feb 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 15 Dec 2023 | Recall initiated by company | |
| 7 Feb 2024 | Classified by FDA | +54 days |
| 14 Feb 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for a negative bias with quality control (QC) and patient sample results when using the Atellica CH Immunoglobulin M_2 (IgM_2) reagent.
Product as listed by the FDA
Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
Where it was distributed
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.
Nationwide AlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaFloridaGeorgiaIowaIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMaineMichiganMinnesota
Questions about this recall
Why was it recalled?
Potential for a negative bias with quality control (QC) and patient sample results when using the Atellica CH Immunoglobulin M_2 (IgM_2) reagent.
Which lots are affected?
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).
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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