Reported Apr 24, 2013 · Terminated
Siemens Dimension Vista(R) System Vista Drug 4 Calibrator. The device is used as an in vitro diagnostic product.
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?
- Siemens Dimension Vista(R) System Vista Drug 4 Calibrator. The device is used as an in vitro diagnostic product.
- Lot codes and dates
Catalog Number KC460SMN 10472284lot 2KD052exp 5/1/14 and Catalog Number KC460ASMN 10476471lot 2KD053exp 5/1/14
- Amount recalled
- 1,638
Where it was sold
Why it was recalled
Siemens has confirmed complaints of low QC and patient recovery with the Dimension Vista(R) LOCI(R) Digoxin(DIGXN) Flex(R) reagent cartridge when calibrating DIGXN with either Drug 4 Cal (KC460) lot 2KD052 or Drug 4 Cal (KC460A) lot 2KD053. Internal testing has shown an average 15% low bias in the therapeutic range of 0.9 to 2.0 ng/mL.
This product could cause temporary or reversible health problems — stop using it.
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