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

FDA device recall Z-0988-2013 · posted 2013-03-25 · Terminated

Recall details

Recalling firm

Siemens Healthcare Diagnostics, Inc.

Reason for recall

Correlation slope bias and accuracy shift

Action taken

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

Status

Terminated

Product code

JIT

Quantity 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,

Date initiated

2012-10-10

Date posted

2013-03-25

Date terminated

2014-01-08

Location

Tarrytown, NY

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