Siemens ADVIA Chemistry Hemoglobin A1c Reagent Kits Recalled for Bias
Siemens Healthcare Diagnostics is recalling specific lots of ADVIA Chemistry Hemoglobin A1c reagent kits due to a positive bias that may result in inaccurate test results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a risk of harm (inaccurate diagnostic results) where no specific injuries or illnesses have been reported, fitting the criteria for a High severity score.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 3,031 units of ADVIA Chemistry Hemoglobin A1c_3 and A1c_3M Reagent kits. These products are used on ADVIA 1200, 1650, 1800, 2400, and XPT Chemistry Systems for the in vitro diagnostic quantitative determination of Hemoglobin A1c, a diabetes marker, in whole blood.
The recall is due to the reagent in the affected lots demonstrating an increased occurrence of high %HbA1c bias. This positive bias averages 0.6% HbA1c units, with a range from -0.1% to 1.1% HbA1c units. The maximum bias was observed at higher %HbA1c concentrations, and quality control samples may exhibit a similar bias.
The affected lots are 230 (SMN 10485591 and 10379673) and 231 (SMN 10485591). The products were distributed in the states of AZ, NY, CA, IN, LA, MN, OH, MI, NM, and GA, as well as in Mexico and Canada. Users should stop using the affected lots and contact Siemens Healthcare Diagnostics for further instructions.
The recalled product
- 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.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 3,031
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 10379673 (160 tests kit)
Distribution
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