Recall Z-1843-2019— Cytocell Ltd.
Class III · Terminated
Class III FDA medical device recall by Cytocell Ltd., initiated 2019-04-26, terminated 2020-07-16. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: There is an error in the chromomap on the package insert..
- Recalling firm
- Cytocell Ltd.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2019-04-26
- Terminated
- 2020-07-16
- Firm location
- Cambridge, N/A, United Kingdom
Product 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 for recall
There is an error in the chromomap on the package insert.
Data sourced from openFDA. This site is unofficial and independent of the FDA.