Recalls / —
—#149026
Product
Dimension Vista Calcium (CA) Flex reagent cartridge Device Listing No.: D011443 Batch Number: 16060BB
- FDA product code
- CIC — Cresolphthalein Complexone, Calcium
- Device class
- Class 2
- Medical specialty
- Clinical Chemistry
- 510(k) numbers
- K061792
- Affected lot / code info
- Device Listing No: D011443 Batch Number 16060BB
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.
Root cause (FDA determination)
Under Investigation by firm
Action the firm took
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.
Recalling firm
- Firm
- Siemens Healthcare Diagnostics, Inc.
- Address
- 500 Gbc Dr PO BOX 6101, Ms 514, Newark, Delaware 19702-2466
Distribution
- 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.
Timeline
- Recall initiated
- 2016-08-03
- Posted by FDA
- 2016-10-04
- Terminated
- 2017-05-11
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #149026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.