FDA Recall
Terminated
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.
Recall: Z-1843-2019
·
Initiated April 26, 2019
Recall
- Recall Number
- Z-1843-2019
- Event Number
- 82917
- Firm
- Cytocell Ltd. 418 Cambridge Science Park, Milton Road Oxford Gene Technology Cambridge United Kingdom
- FEI Number
- 3002646096
- Product Code
- MVU
- Status
- Terminated
- Root Cause
- Labeling False and Misleading
- Initiated
- April 26, 2019
- Posted
- June 19, 2019
- Terminated
- July 16, 2020
Description
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.
Reason
There is an error in the chromomap on the package insert.
Action
Urgent Medical Device Recall letters were distributed to customers beginning 4/26/19.
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.
Quantity
400