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.
FDA Recall Z-0988-2013 · Posted 2013-03-25
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Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusTerminated
Product CodeJIT
Date Initiated2012-10-10
Date Terminated2014-01-08
Product Quantity1985 cartons
Reason for Recall
Correlation slope bias and accuracy shift
Firm Action
Siemens sent a Urgent Medical Device Correction letter dated October 16, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Customers were instructed to calibrate with newer lots of Dimension Vista(R) ALP Calibrator as they become available, beginning with lot 2GD011. Customers were also asked to discontinue use and discard any remaining inventory of lot 2AD052. Customers further instructed to complete the attached response form and fax to (302) 631-8467, to indicate they had received the information and to facilitate their no charge replacement.
Further questions please call (302) 631-6311.
Root Cause
Nonconforming Material/Component
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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