CLASS II ONGOING Device recall · Reported 20 Apr 2022 · FDA Enforcement Report
Atellica CH Lithium_2 (LITH_2), Siemens Material Number recalled
Siemens Healthcare Diagnostics is recalling Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11097637, distributed nationwide in the US. The recall was initiated on 9 Feb 2022 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-0931-2022
- FDA event ID
- 89740
- Recalling firm
- Siemens Healthcare Diagnostics, Tarrytown, NY
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 9 Feb 2022
- FDA classified
- 14 Apr 2022
- Reported
- 20 Apr 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 9 Feb 2022 | Recall initiated by company | |
| 14 Apr 2022 | Classified by FDA | +64 days |
| 20 Apr 2022 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results.
Product as listed by the FDA
Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11097637
Where it was distributed
Global Distribution. US Nationwide.
Questions about this recall
Is Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11097637 recalled?
Yes. Siemens Healthcare Diagnostics recalled Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11097637 on 9 Feb 2022. The recall is Class II and its status is Ongoing. Recall number Z-0931-2022.
Why was it recalled?
Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results.
Which lots are affected?
UDI: 00630414287935; Lot Numbers: 110108 110185 110238 110302
Where was it sold?
Global Distribution. US Nationwide.
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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