Recall Z-2610-2017
Siemens Healthcare Diagnostics, Inc. · initiated March 21, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Dimension Vista Prolactin (PRL) Flex reagent cartridge
Codes / lots: Device Listing Number # A836016 Lot # 16112BB, 16148BA,16165BE,16195BA,16223AD,16259BC 16285BE,16312BD,16334BE,17004BA,17038BC
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.
FDA-determined cause: Under Investigation by firm
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.
Details
- Recall number
- Z-2610-2017
- Initiated
- March 21, 2017
- Posted by FDA
- May 5, 2017
- Terminated
- August 3, 2018
- Product code
- CFT – Radioimmunoassay, Prolactin (Lactogen)
- Quantity
- 3,443 units
- 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…
- Recalling firm
- Siemens Healthcare Diagnostics, Inc., Newark, DE
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2606-2017 Class II | Dimension Troponin 1 (TNI) Flex reagent cartridgeThe concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and… | 03/21/2017Terminated |
| Z-2607-2017 Class II | Dimension Vista Digoxin (DIGXN) Flex reagent cartridgeThe concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and… | 03/21/2017Terminated |
| Z-2608-2017 Class II | Dimension Vista Estradiol (E2) Flex reagent cartridgeThe concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and… | 03/21/2017Terminated |
| Z-2609-2017 Class II | Dimension Vista Ferritin (FERR) Flex reagent cartridgeThe concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and… | 03/21/2017Terminated |
| Z-2611-2017 Class II | Dimension Vista Thyroid Stimulating Hormone (TSH) Flex reagent cartridgeThe concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and… | 03/21/2017Terminated |