Recall Z-2606-2017 ยท MMI Immunoassay Method, Troponin Subunit
Siemens Healthcare Diagnostics, Inc.
Dimension Troponin 1 (TNI) Flex reagent cartridge
| Date | May 5, 2017 (initiated Mar 21, 2017) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | 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. |
| Quantity | 70,428 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,It |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081643 | DIMENSION TNI FLEX REAGENT CARTRIDGE, AND CTNI SAMPLE DILUENT WITH MODELS, RF621, KD692 Siemens Healthcare Diagnostics, Jul 3, 2008 |