Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0039-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: August 3, 2016

Date Posted: October 12, 2016

Recall Number: Z-0039-2017

Event ID: 74987

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.

Status: Terminated

Product Quantity: 5,991 cartridges

Code Information:

Device Listing No: D011443 Batch Number 16060BB

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated