FDAFDA · Food and drugs·Recall number Z-0620-2019
ultra2 Genesys Variants Analyzer, REF 03-01-0045 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only.
Published December 26, 2018 · Recall initiated: November 1, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
lack of 510K
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Clark Laboratories, Inc. (dba,Trinity Biotech USA)
- Distributor
- IL, WV, NJ, AZ, MD, UT
- Lot
- all serial numbers
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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