Z-0988-2013Class III

Siemens Dimension Vista(R) Alkaline Phosphatase (ALP) Calibrator The ALP CAL is an in vitro diagnostic...

Name: Z-0988-2013 Siemens Dimension Vista(R) Alkaline Phosphatase (ALP) Calibrator The ALP CAL is an in vitro diagnostic...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2012-10-10
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2012-10-10 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Siemens Dimension Vista(R) Alkaline Phosphatase (ALP) Calibrator The ALP CAL is an in vitro diagnostic product for the calibration of the Alkaline Phosphatase... on 2012-10-10. FDA classified it as Class III and gives the reason as "Correlation slope bias and accuracy shift". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0988-2013
Classification: Class III
Status: Terminated
Initiated: 2012-10-10
Posted: 2013-03-25
Terminated: 2014-01-08
Recalling firm: Siemens Healthcare Diagnostics Inc.
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.
Product code: JIT Calibrator, Secondary
Reason for recall: Correlation slope bias and accuracy shift
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
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.
Quantity in commerce: 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.
Product codes and lots: Lot 2AD052 Catolog KC330

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0988-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0988-2013	Class III	Terminated	Voluntary: Firm initiated	2013-04-03	2013-03-25

Product code JIT

K061818Class IIDimension Vista System Alkaline Phosphatase Calibrator (Alp Cal - Kc330)Dade Behring, Inc. / cleared 2006-07-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)