Recall Z-1120-2013— Siemens Healthcare Diagnostics, Inc
Class II · Terminated
Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc, initiated 2013-03-13, terminated 2015-03-05. FDA's recall record names no specific 510(k) clearance for this event. Product: ADVIA Centaur Vitamin D Assay (500 tests); Reference Number:10631021. For use in the quantitative determination of Vit D.. Reason: Negative bias in patient samples for Vitamin D.
- Recalling firm
- Siemens Healthcare Diagnostics, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-03-13
- Terminated
- 2015-03-05
- Firm location
- East Walpole, MA, United States
Product description
ADVIA Centaur Vitamin D Assay (500 tests); Reference Number:10631021. For use in the quantitative determination of Vit D.
Reason for recall
Negative bias in patient samples for Vitamin D
Data sourced from openFDA. This site is unofficial and independent of the FDA.