Recall Z-0340-2016 ยท LCP Assay, Glycosylated Hemoglobin
Siemens Healthcare Diagnostics, Inc.
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.
| Date | Nov 25, 2015 (initiated Sep 24, 2015) |
| 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. |
| Root cause | Under Investigation by firm |
| Action | Siemens has issued an Urgent Medical Device Recall in the US and an Urgent Field Safety Notice Outside the US on September 24, 2015, instructing customers to discontinue use, discard reagent and request no charge replacement kits for these products. |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110934 | ADVIA CHEMISTRY HEMOGLOBIN A1C_3 (A1C_3) AUTOMATED PRETREATMENT ASSAY Siemens Healthcare Diagnostics, Aug 25, 2011 |