Dimension Vista Thyroid Stimulating Hormone (TSH) Flex reagent cartridge
FDA device recall Z-2611-2017 · posted 2017-05-05 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- JLW
- Quantity affected
- 19, 927.00
- 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,D
- Date initiated
- 2017-03-21
- Date posted
- 2017-05-05
- Date terminated
- 2018-08-03
- Location
- Newark, DE
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4, DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT (K140859) | Siemens Healthcare Diagnostics, Inc. | 2014-11-26 |