CLASS II Device recall · Reported 24 Oct 2018 · FDA Enforcement Report
Advia Centaur Ckmb Calibrator recalled by Siemens Healthcare Diagnostics
Siemens Healthcare Diagnostics is recalling Advia Centaur Ckmb Calibrator, distributed nationwide in the US. The recall was initiated on 24 Jul 2018 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-0113-2019
- FDA event ID
- 80954
- Recalling firm
- Siemens Healthcare Diagnostics, East Walpole, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Jul 2018
- FDA classified
- 15 Oct 2018
- Reported
- 24 Oct 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 24 Jul 2018 | Recall initiated by company | |
| 15 Oct 2018 | Classified by FDA | +83 days |
| 24 Oct 2018 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A potential bias was identified with certain kits compared to the internal standards.
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
ADVIA Centaur CKMB Calibrator, Cat No. 09318028 Product Usage: For in vitro diagnostic use in calibrating ADVIA Centaur systems CKMB assays.
Where it was distributed
US Nationwide Distribution
Questions about this recall
Is Advia Centaur Ckmb Calibrator recalled?
Yes. Siemens Healthcare Diagnostics recalled Advia Centaur Ckmb Calibrator on 24 Jul 2018. The recall is Class II and its status is Terminated. Recall number Z-0113-2019.
Why was it recalled?
A potential bias was identified with certain kits compared to the internal standards.
Which lots are affected?
SMN 10311570 Lot # Expiry UDI # 57834A64 2018-Dec-11 (01)00630414124803(10)57834A64(17)20181211 57835A64 2018-Dec-11 (01)00630414124803(10)57835A64(17)20181211 72519A64 2018-Dec-11 (01)00630414124803(10)72519A64(17)20181211 98115A64 2018-Dec-11 (01)00630414124803(10)98115A64(17)20181211
Where was it sold?
US Nationwide Distribution
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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