Reported Apr 12, 2017 · Terminated
ADVIA Chemistry Enzyme 2 Calibrator, multi-analyte mixture Product Usage: Assays included in Enzyme 2 Calibrator: AST,…
Siemens Healthcare Diagnostics, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.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, Inc. · 500 Gbc Dr Ms 514 · Newark, DE · 19702-2466
Is this the product you have?
- ADVIA Chemistry Enzyme 2 Calibrator
- multi-analyte mixture Product UsageAssays
- included in Enzyme 2 CalibratorAST, AST_c ALT, ALT_c, ALTP5P, ALTP_c, ASTP5P and ASTP_c
- Lot codes and dates
- Lots 6JD079 and 6MD042
- Amount recalled
- 314 calibrators
Where it was sold
- Nationwide
Why it was recalled
Siemens Healthcare Diagnostics has confirmed a positive bias of up to 41% in quality control and patient results for Aspartate Aminotransferase (AST) and Aspartate Aminotransferase concentrated (AST_c) assays following calibration with Advia Chemistry Enzyme 2 Calibrator lots 6JD079 and 6MD042.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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