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Recall Observatory FDA recall evidence

Device product

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

Z-0039-2017

August 03, 2016

Class II

Product summary

Firm
Siemens Healthcare Diagnostics, Inc.
Event
Event 74987
Status
Terminated
Classification
Class II
Quantity
5,991 cartridges
Official record key
device-enforcement:Z-0039-2017

Official wording

Reason: 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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.