Z-0039-2017Class II

Dimension Vista Calcium (CA) Flex reagent cartridge Device Listing No.: D011443 Batch Number: 16060BB

Name: Z-0039-2017 Dimension Vista Calcium (CA) Flex reagent cartridge Device Listing No.: D011443 Batch Number: 16060BB
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2016-08-03
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2016-08-03 / Terminated

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Dimension Vista Calcium (CA) Flex reagent cartridge Device Listing No.: D011443 Batch Number: 16060BB on 2016-08-03. FDA classified it as Class II and gives the reason as "Siemens Healthcare Diagnostics determined that the Dimension Vista Calcium (CA) Flex reagent cartridge lot # 16060BB may produce erroneously low or high results from specific well sets". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0039-2017
Classification: Class II
Status: Terminated
Initiated: 2016-08-03
Posted: 2016-10-04
Terminated: 2017-05-11
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Dimension Vista Calcium (CA) Flex reagent cartridge Device Listing No.: D011443 Batch Number: 16060BB
Product code: CIC Cresolphthalein Complexone, Calcium
Reason for recall: Siemens Healthcare Diagnostics determined that the Dimension Vista Calcium (CA) Flex reagent cartridge lot # 16060BB may produce erroneously low or high results from specific well sets.
FDA root cause: Under Investigation by firm
Action: Siemens mailed on August 09, 2016, an Urgent Medical Device Recall letter to all customers who purchased the CA lot 16060BB. The notification letter requested that customers discontinue use and discard the affected kit.
Quantity in commerce: 5,991 cartridges
Distribution: Distributed Nationwide and the countries of : Austria, Bahamas, Belgium, Canada, Czech Republic, Denmark, Germany, Italy, Japan, Netherlands, Portugal, Saudi Arabia, South Korea, Slovenia, and Spain.
Product codes and lots: Device Listing No: D011443 Batch Number 16060BB

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0039-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0039-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-12	2016-10-04

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)