Luminex Corporation recalls ARIES HSV 1&2 Assay, Part Number/REF 50-10017
Impacted lot may leak inside the ARIES instrument.
Read the official notice →- Date
- 2022-01-26
- Country
- United States
- Brand
- Luminex
- Product
- ARIES HSV 1&2 Assay, Part Number/REF 50-10017
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide distribution in the states of Alabama,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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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Impacted lot may leak inside the ARIES instrument. Testing confirmed a leak rate of 0.9%. Leaking cassettes could potentially lead to incorrect results or a delay in reporting results due to an Invalid.
FDA · DeviceLuminex CorporationWorldwide distribution - US Nationwide distribution in the states of New…Official notice →
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