Recall Z-0340-2016
Siemens Healthcare Diagnostics, Inc. · initiated September 24, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: 10379673 (160 tests kit), 10485591 (800 tests kit) Lot 230 (SMN 10485591 and 10379673) and lot 231(SMN 10485591)
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.
FDA-determined cause: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-0340-2016
- Initiated
- September 24, 2015
- Posted by FDA
- November 25, 2015
- Terminated
- January 13, 2017
- Product code
- LCP – Assay, Glycosylated Hemoglobin
- 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.
- Recalling firm
- Siemens Healthcare Diagnostics, Inc., Newark, DE