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.
Reported: April 3, 2013 Initiated: October 10, 2012 #Z-0988-2013
Product Description
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.
Reason for Recall
Correlation slope bias and accuracy shift
Details
- Recalling Firm
- Siemens Healthcare Diagnostics, Inc.
- Units Affected
- 1985 cartons
- Distribution
- Nationwide distribution: USA including Puerto Rico and the states of AL, OH, MO, GA, IL, CT, IA, SC, VA, TX, FL, NY, NC, CA, NM, AZ, CA, MI, NJ, PR, MS, NE, WV, PA, MT, MA, MD, KS, NH, TN, VT, LA, CO, ID, WA, NH, DE and OR.
- Location
- Tarrytown, NY
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: 1985 cartons.
Why was this product recalled? ▼
Correlation slope bias and accuracy shift
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 3, 2013. Severity: Low. Recall number: Z-0988-2013.
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