CLASS II ONGOING Device recall · Reported 15 Sep 2021 · FDA Enforcement Report
Atellica IM BR 27.29 (BR) Assay 250 Test Kit recalled
Siemens Healthcare Diagnostics is recalling Atellica IM BR 27.29 (BR) Assay 250 Test Kit- in vitro diagnostic use in the quantitative, distributed nationwide in the US. The recall was initiated on 6 Jul 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-2425-2021
- FDA event ID
- 88431
- Recalling firm
- Siemens Healthcare Diagnostics, East Walpole, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 6 Jul 2021
- FDA classified
- 3 Sep 2021
- Reported
- 15 Sep 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Test Kits & Diagnostics
Timeline
| 6 Jul 2021 | Recall initiated by company | |
| 3 Sep 2021 | Classified by FDA | +59 days |
| 15 Sep 2021 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product does not meet the Instructions for Use (IFU) claimed Pack Calibration Interval of 10 days. IFU calibration updated interval from 10 days to 3 days for all current and future kit lot numbers
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Atellica IM BR 27.29 (BR) Assay 250 Test Kit- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in human serum and plasma (EDTA) using the Atellica IM Analyzer. SMN: 10995477
Where it was distributed
Worldwide distribution. US Nationwide, Australia, Bahamas, India, Mexico, Saudi Arabia, and Viet Nam
Questions about this recall
Why was it recalled?
Product does not meet the Instructions for Use (IFU) claimed Pack Calibration Interval of 10 days. IFU calibration updated interval from 10 days to 3 days for all current and future kit lot numbers
Which lots are affected?
All lots impacted Kit lot numbers: 48553255 & 78009255 expiration date 2021-08-03, Lot number: 90311257 expiration date 2021-11-10.
Where was it sold?
Worldwide distribution. US Nationwide, Australia, Bahamas, India, Mexico, Saudi Arabia, and Viet Nam
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.
Other products in this recall event
2 other products · FDA event 88431| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Atellica IM BR 27.29 (BR) Assay 250 Test Kit (Reference) recalled | Siemens Healthcare Diagnostics | Device Malfunction | Nationwide | |
| CLASS II | Atellica IM BR 27.29 (BR) Assay 50 Test Kit recalled | Siemens Healthcare Diagnostics | Device Malfunction | Nationwide |
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