Recalls / —
—#140899
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.
- FDA product code
- LCP — Assay, Glycosylated Hemoglobin
- Device class
- Class 2
- Medical specialty
- Hematology
- 510(k) numbers
- K110934
- Affected lot / code info
- 10379673 (160 tests kit), 10485591 (800 tests kit) Lot 230 (SMN 10485591 and 10379673) and lot 231(SMN 10485591)
Why it was recalled
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 (FDA determination)
Under Investigation by firm
Action the firm took
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.
Recalling firm
- Firm
- Siemens Healthcare Diagnostics, Inc.
- Address
- 500 Gbc Dr PO BOX 6101, Ms 514, Newark, Delaware 19702-2466
Distribution
- 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.
Timeline
- Recall initiated
- 2015-09-24
- Posted by FDA
- 2015-11-25
- Terminated
- 2017-01-13
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #140899. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.