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.
This recall has been terminated (originally issued November 1, 2018).
- Recall Initiated
- November 1, 2018
- Terminated
- June 21, 2022
- Recall Number
- Z-0620-2019
- Quantity
- 14 devices
- Firm Location
- Jamestown, NY
- Official Source
- View on FDA website ↗
Reason for Recall
lack of 510K
Distribution
IL, WV, NJ, AZ, MD, UT
Lot / Code Info
all serial numbers
Root Cause
No Marketing Application
Action Taken
The firm initiated the recall by letter on 11/01/2018. The letter explained the problem and requested the return of the recalled items.
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