Z-1843-2019Class III

Aquarius D13S319 Plus Deletion Probe, Model LPH068-A

Name: Z-1843-2019 Aquarius D13S319 Plus Deletion Probe, Model LPH068-A
Creator: Cytocell Ltd.
Published: 2019-04-26
License: https://open.fda.gov/license/

Cytocell Limited / initiated 2019-04-26 / Terminated / root cause: labeling and UDI

FDA source

Cytocell Ltd. began a recall of 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... on 2019-04-26. FDA classified it as Class III and gives the reason as "There is an error in the chromomap on the package insert". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1843-2019
Classification: Class III
Status: Terminated
Initiated: 2019-04-26
Posted: 2019-06-19
Terminated: 2020-07-16
Recalling firm: Cytocell Limited
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.
Product code: MVU Reagents, Specific, Analyte
Reason for recall: There is an error in the chromomap on the package insert.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: Urgent Medical Device Recall letters were distributed to customers beginning 4/26/19.
Quantity in commerce: 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.
Product codes and lots: Lot Numbers: 058585, 061111, 061354, 062527

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1843-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1843-2019	Class III	Terminated	Voluntary: Firm initiated	2019-06-26	2019-06-19

Product code MVU

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)