Siemens Healthcare Diagnostics, Inc.: Siemens Dimension Vista(R) System Vista Drug 4 Calibrator. The device is used as an in vitro diagnostic product.

Recall number

Z-1151-2013

Recalling firm

Siemens Healthcare Diagnostics, Inc.

Product

Siemens Dimension Vista(R) System Vista Drug 4 Calibrator. The device is used as an in vitro diagnostic product.

Status

Terminated

Initiated

2013-02-21

Posted

2013-04-18

Terminated

2014-01-07

Reason

Siemens has confirmed complaints of low QC and patient recovery with the Dimension Vista(R) LOCI(R) Digoxin(DIGXN) Flex(R) reagent cartridge when calibrating DIGXN with either Drug 4 Cal (KC460) lot 2KD052 or Drug 4 Cal (KC460A) lot 2KD053. Internal testing has shown an average 15% low bias in the therapeutic range of 0.9 to 2.0 ng/mL.

Root cause

Process control

Action

The firm initiated their recall of this product by sending an Urgent Medical Device Recall letter dated February 2013 to all Dimension Vista Drug 4 Calibrator customers who received the affected lots. The letter notified them of the issue, the potential risk to health, and actions to be taken by customers.

Quantity

1,638

Distribution

Distributed within the US to AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.

Lot, serial or model codes

Catalog Number KC460, SMN 10472284, lot 2KD052, exp 5/1/14 and Catalog Number KC460A, SMN 10476471, lot 2KD053, exp 5/1/14.

510(k) numbers

["K093441","K112142"]

PMA numbers

not on file

Product code

KXT

Firm FEI

2517506

Firm city

Newark

Firm state

DE

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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