—#114030

Product

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 product code: JIT — Calibrator, Secondary
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K061818
Affected lot / code info: Lot 2AD052 Catolog KC330

Why it was recalled

Correlation slope bias and accuracy shift

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 511 Benedict Avenue, Tarrytown, New York 10591-5097

Distribution

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.

Timeline

Recall initiated: 2012-10-10
Posted by FDA: 2013-03-25
Terminated: 2014-01-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #114030. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.