Dimension Vista Calcium (CA) Flex reagent cartridge recallZ-0039-2017 · Siemens Healthcare Diagnostics, Inc. · initiated Aug 3, 2016
Class II Terminated All recalls posted in October 2016
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-0039-2017
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Aug 3, 2016
- Posted by the FDA
- Oct 4, 2016
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 5,991 cartridges
- Product code
- CIC
- FDA submissions
- K061792
- 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.
Product description
Dimension Vista Calcium (CA) Flex reagent cartridge Device Listing No.: D011443 Batch Number: 16060BB
Code information (models, lots, serial numbers)
Device Listing No: D011443 Batch Number 16060BB
Other devices under the same FDA submission
1 device cleared under K061792 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Dimension Vista® Flex® reagent cartridge CA 10445160Siemens Healthcare Diagnostics Inc. · CRESOLPHTHALEIN COMPLEXONE, CALCIUM49 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page