Reported Jun 28, 2017 · Terminated
Dimension Troponin 1 (TNI) Flex reagent cartridge
Siemens Healthcare Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Healthcare Diagnostics, Inc. · 500 Gbc Dr Ms 514 · Newark, DE · 19702-2466
Is this the product you have?
- Dimension Troponin 1 (TNI) Flex reagent cartridge
- Lot codes and dates
Device Listing Number # D056469 Lot # EB7091EC7104EA7125ED7193EA7161EB7173EC7229ED7236 EA7250ED7271EB7315EB7342 "
- Amount recalled
- 70,428 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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