Siemens ADVIA Centaur CA 19-9 Assay Recalled for Performance Issues
Siemens is recalling ADVIA Centaur CA 19-9 Assay kits because they do not meet performance standards on the ADVIA Centaur CP system.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 18,733 kits of the ADVIA Centaur CA 19-9 Assay. The recall affects kits with lot numbers ending in 380, 382, 384, 386, 388, and 390, as well as all future lots until the issue is resolved. The affected kits are intended for use with the ADVIA Centaur, ADVIA Centaur XP, ADVIA Centaur XPT, and ADVIA Centaur CP systems.
The recall was initiated because the CA 19-9 assay on the ADVIA Centaur CP system does not meet the correlation to the CA 19-9 assay on the ADVIA Centaur, XP, and XPT systems as stated in the Instructions for Use. The agency classification for this recall is Class II.
The affected products were distributed nationwide and in numerous foreign countries. Siemens plans to request CLIA Categorization for the CA 19-9 assay on the XPT instrument. Siemens will include a notecard in future lots of reagents referring customers to the communications regarding this issue.
The recalled product
- Product
- ADVIA Centaur CA 19-9 Assay (50 test kit)-for use, with the ADVIA Centaur and ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP systems. Siemens Material Number(SMN): 10491379 In the 510(k) database the CA 19-9 assay is not CLIA categorized on the ADVIA Centaur XPT in
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Hazard
- Affected units
- 18,733
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Kit lots ending in: 380 Exp Date 2016-10-21
- 382/ 2017-01-09
- 384 2017-02-06
- 386 2017-03-24
- 388 2017-05-14
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Siemens Healthcare Diagnostics, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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