Siemens ADVIA Centaur Folate Diluent Recalled for Low Recovery Results
Siemens Healthcare Diagnostics is recalling ADVIA Centaur Folate Ascorbic Acid Diluent because it causes low red blood cell control recoveries and low patient sample results.
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, which typically indicates a situation where use may cause temporary or medically reversible health consequences. The hazard is inaccurate test results rather than direct physical injury or death.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 466 units of ADVIA Centaur Folate Ascorbic Acid/Ascorbic Acid Diluent (SMN 10316877). This product is used to prepare red blood cell hemolysate for the ADVIA Centaur systems folate assay. The recall affects specific lots with expiration dates of November 17, 2015.
The recall was initiated because the diluent results in low red blood cell control recoveries and low results for red blood cell patient samples when used with the ADVIA Centaur Systems Folate assay. This issue may lead to inaccurate diagnostic testing.
The affected product was distributed worldwide, including nationwide in the United States and in several international countries. Users should stop using the affected lots and contact Siemens Healthcare Diagnostics for further instructions.
The recalled product
- Product
- ADVIA Centaur¿ Folate Ascorbic Acid/Ascorbic Acid Diluent; SMN 10316877. Used to prepare the Red Blood Cell hemolysate for use with the ADVIA Centaur systems folate assay.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Hazard
- Affected units
- 466
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 (3)
- Lot Number/Expiration: 54942 2015-11-17
- 56230 2015-11-17
- 70673 2015-11-17
Distribution
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