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.
FDA Recall Z-0340-2016 · Posted 2015-11-25
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Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusTerminated
Product CodeLCP
Date Initiated2015-09-24
Date Terminated2017-01-13
Product Quantity3031
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.
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.
Root Cause
Under Investigation by firm
Distribution Pattern
Distributed in the states of AZ, NY, CA, IN, LA, MN, OH, MI, NM, and GA, and the countries of Mexico and Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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