Device product
Aquarius D13S319 Plus Deletion Probe, Model LPH068-A Product Usage: The D13S319 probe, labelled in red, covers a 156kb region including most of the DLEU2 gene, part of the DLEU1 gene and the D13S319 and D13S272 markers. The 13qter subtelomere specific probe, labelled in green, allows identification of chromosome 13 and acts as a control probe.
Z-1843-2019
Product summary
- Firm
- Cytocell Ltd.
- Event
- Event 82917
- Status
- Terminated
- Classification
- Class III
- Quantity
- 400
- Official record key
device-enforcement:Z-1843-2019
Official wording
Reason: There is an error in the chromomap on the package insert.
Code information: Lot Numbers: 058585, 061111, 061354, 062527
Distribution pattern: Worldwide Distribution - US Nationwide AL, CO, FL, HI, IA, IL, IN, KY, MA, MD, MI, MO, MS, NC, NJ, NY, TN, TX, UT, WA, and WI. The products were distributed to the following foreign countries: Canada.
Derived failure modes
-
Unknown
There is an error in the chromomap on the package insert.