Reported Sep 24, 2014 · Terminated
ADVIA Chemistry A1c_3 CAL (Calibrator) for use on the ADVIA Chemistry Systems, REF/Catalog Number/Siemens Material…
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 CAL (Calibrator) for use on the ADVIA Chemistry Systems, REF/Catalog Number/Siemens Material Number (SMN) 10491408, IVD ADVIA Chemistry A1c_3
- Calibrator InformationFor 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. The 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
- Lot codes and dates
Lots 3HD044 (exp. 11/01/2015)and 3LD068 (exp. 01/01/2016)
- Amount recalled
- Domestic: 1122 kits; Foreign: 236 kits
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
The ADVIA Chemistry Systems A1c_3 method may exhibit a percent bias of -9% to +11% for hemoglobin (Hb)A1c samples when using A1c_3 Calibrator lots 3HD044 and 3LD068. Depending on quality control limits, this issue may not have been detected. NOTE: The percent bias range is a percentage of the HbA1c result. It is NOT absolute HbA1c units.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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