Reported Oct 12, 2016 · Terminated
Dimension Vista¿ Calcium (CA) Flex¿ reagent cartridge Device Listing No.: D011443 Batch Number: 16060BB
Siemens Healthcare Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Healthcare Diagnostics, Inc. · 500 Gbc Dr Ms 514 · Newark, DE · 19702-2466
Is this the product you have?
- Dimension Vista¿ Calcium (CA) Flex¿ reagent cartridge Device Listing No.:
- D011443 Batch Number16060BB
- Lot codes and dates
- Device Listing NoD011443 Batch Number 16060BB
- Amount recalled
- 5,991 cartridges
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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