ADVIA Centaur Folate — Class II medical device recall Z-2171-2013
Terminated recall by Siemens Healthcare Diagnostics, Inc, reported 2013-09-18, distributed in AL, AR, AZ, CA, CO, CT, DE, FL…. Calibration failures and/or significant negative shifts in quality control (QC) and patient results.
| Recall number | Z-2171-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc, East Walpole, MA, United States |
| Recall initiated | 2013-07-25 |
| Classified | 2013-09-10 |
| Reported by FDA | 2013-09-18 |
| Terminated | 2015-06-12 |
| Distributed | 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 |
| Countries outside the US | CA, MX |
| Quantity | 488 |
| Model numbers | 00203473, 10331250 |
Product
ADVIA Centaur Folate (500 tests), REF SMN 10331250, Cat No. 00203473 In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells.
Reason for recall
Calibration failures and/or significant negative shifts in quality control (QC) and patient results.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2171-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.