FDA Device recall Z-2739-2015
ADVIA Centaur¿ Folate Ascorbic Acid/Ascorbic Acid Diluent
- FDA Device
- Class II
- terminated
- Published 2015-09-16
On 2015-09-16 the FDA classified a Class II recall of ADVIA Centaur¿ Folate Ascorbic Acid/Ascorbic Acid Diluent by Siemens Healthcare Diagnostics, citing low red blood cell control recoveries and low results for red blood cell patient samples when using the ADVIA Centaur Systems Folate assay.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2739-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-07-27 |
| Published | 2015-09-16 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
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.
Reason
Low red blood cell control recoveries and low results for red blood cell patient samples when using the ADVIA Centaur Systems Folate assay.
Identifiers
| code_info | Lot Number/Expiration: 54942 2015-11-17; 56230 2015-11-17; 70673 2015-11-17 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2739-2015%22
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