ADVIA Chemistry Hemoglobin A1c_3 — Class II medical device recall Z-0340-2016
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2015-12-02, distributed in AZ, CA, GA, IN, LA, MI, MN, NM…. Reagent in these lots may demonstrate an increased occurrence of high %HbA1c bias, a positive bias averaging 0
| Recall number | Z-0340-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Newark, DE, United States |
| Recall initiated | 2015-09-24 |
| Classified | 2015-11-25 |
| Reported by FDA | 2015-12-02 |
| Terminated | 2017-01-13 |
| Distributed | AZ, CA, GA, IN, LA, MI, MN, NM, NY, OH |
| Countries outside the US | CA, MX |
| Quantity | 3,031 |
| Lot numbers | 230, 231 |
Product
ADVIA Chemistry Hemoglobin A1c_3, A1c_3M Reagent kits. Used on the ADVIA 1200, 1650, 1800, 2400, and XPT Chemistry Systems. For in vitro diagnostic use in the quantitative determination of Hemoglobin A1c, a diabetes marker, in whole blood on the ADVIA Chemistry systems.
Reason for recall
Reagent in these lots may demonstrate an increased occurrence of high %HbA1c bias, a positive bias averaging 0.6% HbA1c units, ranging from -0.1% to 1.1% HbA1c units. The maximum bias was observed at higher %HbA1c concentrations. QC samples may exhibit a similar bias.
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-0340-2016. 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.