Reported Apr 3, 2013 · Terminated

Siemens Dimension Vista(R) Alkaline Phosphatase (ALP) Calibrator The ALP CAL is an in vitro diagnostic product for the…

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. · 511 Benedict Avenue · Tarrytown, NY · 10591-5097

Is this the product you have?

  • Siemens Dimension Vista(R) Alkaline Phosphatase (ALP) Calibrator The ALP CAL is an in vitro diagnostic product for the calibration of the Alkaline Phosphatase method on the Dimension Vista" System.
Lot codes and dates
  • Lot 2AD052 Catolog KC330
Amount recalled
1985 cartons

Where it was sold

Why it was recalled

Correlation slope bias and accuracy shift

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jan 8, 2014 · Data as of Sep 19, 4:54 PM UTC

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