Aquarius D13S319 Plus Deletion Probe — Class III medical device recall Z-1843-2019
Terminated recall by Cytocell Ltd., reported 2019-06-26, distributed nationwide. There is an error in the chromomap on the package insert.
| Recall number | Z-1843-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cytocell Ltd., Cambridge, N/A, United Kingdom |
| Recall initiated | 2019-04-26 |
| Classified | 2019-06-19 |
| Reported by FDA | 2019-06-26 |
| Terminated | 2020-07-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 400 |
| Lot numbers | 058585, 061111, 061354, 062527 |
| Model numbers | DLEU1, LPH068-A |
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 for recall
There is an error in the chromomap on the package insert.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1843-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.