Reported Sep 11, 2013 · Terminated
ADVIA Chemistry A1c_3 Calibrators, Catalog Number 10491408, IVD --- COMMON/USUAL NAME: ADVIA Chemistry A1c_3…
Siemens Healthcare Diagnostics
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Healthcare Diagnostics · 511 Benedict Ave · Tarrytown, NY · 10591-5005
Is this the product you have?
ADVIA Chemistry A1c_3 CalibratorsCatalog Number 10491408
- IVD --- COMMON/USUAL NAMEADVIA Chemistry A1c_3
- Calibrators Shipping or unit packageLevel 1: 2 x 0.5 g
- Level 22 x 0.5 g
- Level 32 x 0.5 g
- Level 42 x 0.5 g -- Siemens Healthcare Diagnostics, Inc. Tarrytown
- NY 10591 --- System InformationThe ADVIA Chemistry systems are automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine in random access and batch modes for in vitro diagnostic use. For in vitro diagnostic use in the calibration of A1c_3 (A1c_3 and A1c_3M) and Total Hemoglobin_3 (tHb_3 and tHb_3M) methods on ADVIA¿ Chemistry systems
- Lot codes and dates
Lots 1MD014 (exp. date 5/01/2013)1BD063 (exp. 5/01/2013)2GD014 (exp. 10/01/2014)
- Amount recalled
- US: 1546 units; Foreign: 518 units
Where it was sold
- Nationwide
- PR
Why it was recalled
Siemens confirmed that the ADVIA¿ Chemistry Systems HbA1c method exhibits a positive bias of up to 12% for patient and CAP survey samples due to over-recovery when using A1c_3 Calibrator lots 1MD014, 1BD063, and 2GD014. The established ranges of CAP Survey Samples GH2-04, GH2-05 and GH2-06 and IFCC sample recoveries use ¿ 7% from the established mean as their acceptance criteria. This is the criterion that was used during testing to confirm the customer complaints. Depending upon quality control limits this issue may not have been detected..
This product could cause temporary or reversible health problems — stop using it.
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