Z-1540-2018Class II

Dimension Vista Calcium Flex reagent cartridge, Dimension Vista CA, K1023, SMN # 10445160 The CA method is an...

Name: Z-1540-2018 Dimension Vista Calcium Flex reagent cartridge, Dimension Vista CA, K1023, SMN # 10445160 The CA method is an...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2018-01-30
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2018-01-30 / Terminated

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Dimension Vista Calcium Flex reagent cartridge, Dimension Vista CA, K1023, SMN # 10445160 The CA method is an in vitro diagnostic test for the quantitative... on 2018-01-30. FDA classified it as Class II and gives the reason as "May produce erroneously low results from specific well sets". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1540-2018
Classification: Class II
Status: Terminated
Initiated: 2018-01-30
Posted: 2018-04-27
Terminated: 2019-05-16
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Dimension Vista Calcium Flex reagent cartridge, Dimension Vista CA, K1023, SMN # 10445160 The CA method is an in vitro diagnostic test for the quantitative measurement of calcium in human serum, plasma, and urine on the Dimension Vista System.
Product code: CIC Cresolphthalein Complexone, Calcium
Reason for recall: May produce erroneously low results from specific well sets.
FDA root cause: Under Investigation by firm
Action: An Urgent Medical Device Recall and an Urgent Field Safety Notice were issued on January 30, 2018 to all Dimension Vista customers who purchased the impacted lot to notify them of the issue, the potential risk to health, and actions to be taken by the customer. Customers were instructed to: "Discontinue use of and discard the Dimension Vista Calcium Flex reagent lot 17171BD. "Please review this letter with your Medical Director. "Review your inventory of these products to determine your laboratorys replacement needs and to provide information to Siemens for reporting to the authorities. "Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. If you have received any complaints of illness or adverse events associated with the product listed in Table 1, immediately contact your local Siemens Customer Care Center or your local Siemens Technical Support Representative. For further questions, please call (312) 275-7795.
Quantity in commerce: 6000
Distribution: Worldwide Distribution - USA (nationwide) and to the following countries: Australia, Austria, Belgium, Canada, Czech Republic, Denmark, France, Germany, Italy, Japan, Norway, Portugal, Slovakia, Slovenia, South Korea, Spain, Switzerland
Product codes and lots: Lot # 17171BD, UDI # (UDI) 0084276801561817171BD18062010445160 EXP. 06-20-2018

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1540-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1540-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-09	2018-04-27

Product code CIC

K061792Class IIDimension Vista Ethyl Alcohol (Alc), Alkaline Phosphatase (Alp), Calcium (Ca0 Flex, Lactic Acid (La) Flex Reagent CartriDade 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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)