Recall Z-1843-2019 ยท MVU Reagents, Specific, Analyte
Cytocell Ltd.
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.
| Date | Jun 19, 2019 (initiated Apr 26, 2019) |
| Status | Terminated |
| Reason | There is an error in the chromomap on the package insert. |
| Root cause | Labeling False and Misleading |
| Action | Urgent Medical Device Recall letters were distributed to customers beginning 4/26/19. |
| Quantity | 400 |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.