FDA Device recall Z-1843-2019
Aquarius D13S319 Plus Deletion Probe, Model LPH068-A Product Usage: The D13S319 probe, labelled in red, covers a 156kb region including mos…
- FDA Device
- Class III
- terminated
- Published 2019-06-26
On 2019-06-26 the FDA classified a Class III recall of Aquarius D13S319 Plus Deletion Probe, Model LPH068-A Product Usage: The D13S319 probe, labelled in red, covers a 156kb region including mos… by Cytocell, citing there is an error in the chromomap on the package insert.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1843-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2019-04-26 |
| Published | 2019-06-26 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Cytocell |
| Distribution | US |
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.
Identifiers
| code_info | Lot Numbers: 058585, 061111, 061354, 062527 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1843-2019%22
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