CLASS II ONGOING Device recall · Reported 11 Dec 2024 · FDA Enforcement Report
Atellica¿ CH ¿2-Microglobulin (B2M) recalled
Siemens Healthcare Diagnostics is recalling Atellica¿ CH ¿2-Microglobulin (B2M) - In vitro diagnostic use in the quantitative, distributed nationwide in the US. The recall was initiated on 21 Oct 2024 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-0599-2025
- FDA event ID
- 95666
- Recalling firm
- Siemens Healthcare Diagnostics, Tarrytown, NY
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 21 Oct 2024
- FDA classified
- 4 Dec 2024
- Reported
- 11 Dec 2024
- Type
- Voluntary: Firm initiated
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 21 Oct 2024 | Recall initiated by company | |
| 4 Dec 2024 | Classified by FDA | +44 days |
| 11 Dec 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 falsely depressed auto-diluted results for samples above the measuring interval of 18.00 mg/L, up to 30.00 mg/L, when using the Atellica CH ¿2-Microglobulin (B2M) reagent.
Product as listed by the FDA
Atellica¿ CH ¿2-Microglobulin (B2M) - In vitro diagnostic use in the quantitative determination of ¿2-microglobulin in human serum and plasma. Siemens Material Number (SMN): 11097635
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hungary, India, Iran, Israel, Italy, Ivory Coast, Japan, Jordan, Kuwait, Mexico, Morocco, Oman, P.R. China, Pakistan, Paraguay, Poland, Portugal, Saudi Arabia, Saudi Arabia, Serbia, Slovakia, South Africa, Spain, Switzerland, Thailand, Turkey, U.A.E., Uganda, United Kingdom, Uruguay, Uzbekistan, Vietnam, Zaire.
Questions about this recall
Is Atellica¿ CH ¿2-Microglobulin (B2M) - In vitro diagnostic use in the quantitative recalled?
Yes. Siemens Healthcare Diagnostics recalled Atellica¿ CH ¿2-Microglobulin (B2M) - In vitro diagnostic use in the quantitative on 21 Oct 2024. The recall is Class II and its status is Ongoing. Recall number Z-0599-2025.
Why was it recalled?
Potential for falsely depressed auto-diluted results for samples above the measuring interval of 18.00 mg/L, up to 30.00 mg/L, when using the Atellica CH ¿2-Microglobulin (B2M) reagent.
Which lots are affected?
UDI-DI: 00630414595566 All in-date and future Atellica CH B2M reagent lots
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hungary, India, Iran, Israel, Italy, Ivory Coast, Japan, Jordan, Kuwait, Mexico, Morocco, Oman, P.R. China, Pakistan, Paraguay, Poland, Portugal, Saudi Arabia, Saudi Arabia, Serbia, Slovakia, South Africa, Spain, Switzerland, Thailand, Turkey, U.A.E., Uganda, United Kingdom, Uruguay, Uzbekistan, 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 21 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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