CLASS II Device recall · Reported 5 Jan 2022 · FDA Enforcement Report
Atellica CH ¿2-Microglobulin (B2M) -M) Assay recalled
Siemens Healthcare Diagnostics is recalling Atellica CH ¿2-Microglobulin (B2M) -M) Assay for in vitro diagnostic use in the, distributed nationwide in the US. The recall was initiated on 1 Dec 2021 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-0440-2022
- FDA event ID
- 89211
- Recalling firm
- Siemens Healthcare Diagnostics, Tarrytown, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Dec 2021
- FDA classified
- 29 Dec 2021
- Reported
- 5 Jan 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 1 Dec 2021 | Recall initiated by company | |
| 29 Dec 2021 | Classified by FDA | +28 days |
| 5 Jan 2022 | 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
¿2 Microglobulin (B2M) Reagent Lot 211446 Bias with Quality Control and Patient Sample Results. Positive bias on patient samples of up to +20.9% at a B2M concentration of approximately 1.5 mg/L and a negative bias on patient samples of up to -10.5% at a B2M concentration of approximately 15 mg/L
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Atellica CH ¿2-Microglobulin (B2M) -M) Assay for 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 distribution in the states of CA, CO, MA, MD, MS, NC, NE, NH, OH, VA, WI and the countries of Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Czech Republic, Denmark, Ecuador, France, Germany, Greece, India, Iran, Israel, Italy, Japan, Mexico, Morocco, Oman, P.R. China, Pakistan, Philippines, Portugal, Slovakia, South Africa, Spain, Switzerland, Turkey, United Kingdom, Uruguay.
Nationwide CaliforniaColoradoMassachusettsMarylandMississippiNorth CarolinaNebraskaNew HampshireOhioVirginiaWisconsin
Questions about this recall
Why was it recalled?
¿2 Microglobulin (B2M) Reagent Lot 211446 Bias with Quality Control and Patient Sample Results. Positive bias on patient samples of up to +20.9% at a B2M concentration of approximately 1.5 mg/L and a negative bias on patient samples of up to -10.5% at a B2M concentration of approximately 15 mg/L
Which lots are affected?
Lot Number: 211446 UDI: 00630414595566
Where was it sold?
Worldwide distribution - US Nationwide distribution in the states of CA, CO, MA, MD, MS, NC, NE, NH, OH, VA, WI and the countries of Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Czech Republic, Denmark, Ecuador, France, Germany, Greece, India, Iran, Israel, Italy, Japan, Mexico, Morocco, Oman, P.R. China, Pakistan, Philippines, Portugal, Slovakia, South Africa, Spain, Switzerland, Turkey, United Kingdom, Uruguay.
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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