Reported Mar 5, 2014 · Terminated
Dimension Vista Enzyme 1 Calibrator (ENZ 1 CAL) lots 3FD034 and 3HD012. An in vitro diagnostic multi-analyte calibrator…
Siemens Healthcare Diagnostics, Inc.
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, Inc. · 500 Gbc Dr Ms 514 · Newark, DE · 19702-2466
Is this the product you have?
- Dimension Vista Enzyme 1 Calibrator (ENZ 1 CAL) lots 3FD034 and 3HD012. An in vitro diagnostic multi-analyte calibrator for the calibration of Amylase (AMY), Gamma-Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Lipase (LIPL), and Pseudocholinesterase (PCHE) methods on the Dimension Vista System.
- Lot codes and dates
lot 3FD034exp. 6/17/2014and lot 3HD012exp. 9/1/2014
- Amount recalled
- 3496
Where it was sold
- Nationwide
Why it was recalled
Complaints were received regarding Quality Control (QC) shifts with Pseudocholinesterase (PCHE) and imprecision during PCHE calibration with the Dimension Vista Enzyme 1 Calibrator (ENZ 1 CAL).
This product could cause temporary or reversible health problems — stop using it.
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