FDA Device recall Z-2170-2013
ADVIA Centaur Folate (500 Tests) SMN 10325366, Cat No. 06891541 In vitro diagnostic use in the quantitative determination of folate in seru…
- FDA Device
- Class II
- terminated
- Published 2013-09-18
On 2013-09-18 the FDA classified a Class II recall of ADVIA Centaur Folate (500 Tests) SMN 10325366, Cat No. 06891541 In vitro diagnostic use in the quantitative determination of folate in seru… by Siemens Healthcare Diagnostics, citing calibration failures and/or significant negative shifts in quality control (QC) and patient results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2170-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-07-25 |
| Published | 2013-09-18 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY |
Product
ADVIA Centaur Folate (500 Tests) SMN 10325366, Cat No. 06891541 In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells.
Reason
Calibration failures and/or significant negative shifts in quality control (QC) and patient results.
Identifiers
| code_info | 22289218, 22297218, 22535218 |
|---|
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-2170-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.