Dimension Vista Digoxin (DIGXN) Flex reagent cartridge recallZ-2607-2017 · Siemens Healthcare Diagnostics, Inc. · initiated Mar 21, 2017
Class II Terminated All recalls posted in May 2017
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
The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and Dimension Vistat Instructions for Use (IFU) for Dimension TNI, Dimension Vista DIGXN, E2, FERR, PRL, and TSH have incorrect units, and incorrectly state the level at which biotin does not interfere.
FDA root cause category: Under Investigation by firm
What the company is doing
Siemens mailed an Urgent Medical Device Correction Letter to affected customers on 03/29/2017 to inform them of the issue. The notice explained the reason for the field action, Risk to Health and actions to be taken by the customer.
Recall details
- Recall number
- Z-2607-2017
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Mar 21, 2017
- Posted by the FDA
- May 5, 2017
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 13,143 units
- Product code
- KXT
- FDA submissions
- K093441
- Distribution
- Product was distributed throughout the United States and Canada, United Arab Emirates, Argentina, Austria,Australia,Bangladesh,Belgium,Brazil,Canada Switzerland,China,Columbia,Czech Republic,Germany,Denmark,Algeria Egypt,Spain,Finland,France,Great Britain,Greece,Croatia,Indonesia,Ireland India,Italy,Japan,Canary Islands,Republic of Korea,Kuwait,Lebanon,Latvia Macedonia,Netherlands,Norway,New Zealand,Philippines,Poland,Portugal Qatar,Saudi Arabia,Slovenia,Slovakia,Turkey,Taiwan,South Africa
Product description
Dimension Vista Digoxin (DIGXN) Flex reagent cartridge
Code information (models, lots, serial numbers)
Device Listing Number # D098364 Lot # 16103BD, 16195BB, 16230BA, 16259BD, 16320BD, 16363BA
Other devices under the same FDA submission
1 device cleared under K093441 — 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 DIGXN 10488927Siemens Healthcare Diagnostics Inc. · ENZYME IMMUNOASSAY, DIGOXIN15 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 76915).
- Z-2606-2017 · TerminatedDimension Troponin 1 (TNI) Flex reagent cartridge
- Z-2611-2017 · TerminatedDimension Vista Thyroid Stimulating Hormone (TSH) Flex reagent cartridge
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.
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