Siemens Healthcare Diagnostics, Inc. recalls Dimension LTNI -In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human serum and…
Positive bias with Lithium Heparin plasma samples from individuals that are expected to be below the 99th percentile of 0.07 ng/mL [0.07 ¿g/L], may lead to inappropriate intervention for myocardial infarction
Read the official notice →- Date
- 2022-07-13
- Country
- United States
- Brand
- Siemens Healthcare Diagnostics
- Product
- Dimension LTNI -In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human serum and heparinized plasma…
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide distribution in the states of AL, AR,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
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