Device recall: Dimension Troponin 1 (TNI) Flex reagent cartridge
Class II FDA enforcement event 76915. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
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.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Siemens Healthcare Diagnostics, Inc. started this device recall on 21 Mar 2017. The firm address in the FDA record is in Newark, DE. FDA put the recall in Class II. FDA event 76915 has 6 product records. The first FDA enforcement report date is 28 Jun 2017. The record gives the status Terminated, with the termination date 3 Aug 2018.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Product was distributed throughout the United States and Canada, United Arab Emirates, Argentina, Austria,Australia,Bangladesh,Belgium,Brazil,Canada Switzerland,China,Columbia,Czech…
Recalling firm
Siemens Healthcare Diagnostics, Inc., Newark, DE.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
6 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2606-2017 | Dimension Troponin 1 (TNI) Flex reagent cartridge | 70,428 units | Class II | Terminated | 28 Jun 2017 |
| Z-2607-2017 | Dimension Vista Digoxin (DIGXN) Flex reagent cartridge | 13,143 units | Class II | Terminated | 28 Jun 2017 |
| Z-2608-2017 | Dimension Vista Estradiol (E2) Flex reagent cartridge | 1,697 units | Class II | Terminated | 28 Jun 2017 |
| Z-2609-2017 | Dimension Vista Ferritin (FERR) Flex reagent cartridge | 29,266 units | Class II | Terminated | 28 Jun 2017 |
| Z-2610-2017 | Dimension Vista Prolactin (PRL) Flex reagent cartridge | 3,443 units | Class II | Terminated | 28 Jun 2017 |
| Z-2611-2017 | Dimension Vista Thyroid Stimulating Hormone (TSH) Flex reagent cartridge | 19, 927.00 | Class II | Terminated | 28 Jun 2017 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2017
- 1,091
- Share of these events in Class II
- 93%
- Product records in this event
- 6Median of the firm: 1
- Events of the firm on the register
- 333
Other events of the firm
Official channels
- FDA enforcement report Z-2606-2017The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 76915. https://recallregister.com/fda/ii/76915/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Product was distributed throughout the United States and Canada, United Arab Emirates, Argentina, Austria,Australia,Bangladesh,Belgium,Brazil,Canada Switzerland,China,Columbia,Czech…
- What quantity of product is in FDA event 76915?
- The event has 6 product records. The first record gives this quantity:
70,428 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2017 have the same class?
- 93% of the 1,091 device events that started in 2017 are in Class II.