Class II — Siemens Healthcare Diagnostics, Inc.
| Recalling firm | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
|---|---|
| Registered facility | View this company's 12 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| 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. |
| Quantity | 3031 |
| Distribution | Distributed in the states of AZ, NY, CA, IN, LA, MN, OH, MI, NM, and GA, and the countries of Mexico and Canada. |
| Initiated | 2015-09-24 |
| Classified | 2015-11-25 |
| Terminated | 2017-01-13 |
| Recall number | Z-0340-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Siemens Healthcare Diagnostics, Inc. (Z-0340-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/72392/
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