FDA Medical Device Recalls (openFDA)
Siemens Healthcare Diagnostics, Inc.: Dimension Vista Calcium (CA) Flex reagent cartridge Device Listing No.: D011443 Batch Number: 16060BB
- Recall number
- Z-0039-2017
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Product
- Dimension Vista Calcium (CA) Flex reagent cartridge Device Listing No.: D011443 Batch Number: 16060BB
- Status
- Terminated
- Initiated
- 2016-08-03
- Posted
- 2016-10-04
- Terminated
- 2017-05-11
- 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.
- 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
- 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.
- Lot, serial or model codes
- Device Listing No: D011443 Batch Number 16060BB
- 510(k) numbers
- ["K061792"]
- PMA numbers
- not on file
- Product code
- CIC
- Firm FEI
- 2517506
- Firm city
- Newark
- Firm state
- DE
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28