Reported Jan 14, 2015 · Terminated
Dimension Vista Myoglobin Calibrator (MYO CAL), Lot 4FD085 Product usage: in vitro diagnostic product for the…
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 Myoglobin Calibrator (MYO CAL)
- Lot 4FD085 Product usagein vitro diagnostic product for the calibration of Myoglobin (MYO) method on the Dimension Vista System
- Lot codes and dates
Lot 4FD085exp. 12-01-2014
- Amount recalled
- 1230
Where it was sold
- Nationwide
Why it was recalled
Dimension Vista Myoglobin Calibrator (MYO CAL) may produce a positive shift in MYO QC and Patient test results that exceeds acceptance criteria for this product. A positive shift observed up to 12% at MYO concentrations within and above the reference range of the assay. Depending on quality control limits, this drift may not be detected.
This product could cause temporary or reversible health problems — stop using it.
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