Z-2829-2020Class II

Cytocell LPH533-A NUP98 Distal Probe Green -

Name: Z-2829-2020 Cytocell LPH533-A NUP98 Distal Probe Green -
Creator: Cytocell Ltd.
Published: 2020-07-17
License: https://open.fda.gov/license/

Cytocell Limited / initiated 2020-07-17 / Terminated

FDA source

Cytocell Ltd. began a recall of Cytocell LPH533-A NUP98 Distal Probe Green - Product Usage:The NUP98 Distal probe, labelled in green, consists of a 151kb probe distal to the NUP98 gene... on 2020-07-17. FDA classified it as Class II and gives the reason as "A low risk of a false positive result being issued with a laboratory developed test (LDT) that utilizes the LPH533-A NUP98 Distal Probe Green". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2829-2020
Classification: Class II
Status: Terminated
Initiated: 2020-07-17
Posted: 2020-08-20
Terminated: 2020-09-30
Recalling firm: Cytocell Limited
Product: Cytocell LPH533-A NUP98 Distal Probe Green - Product Usage:The NUP98 Distal probe, labelled in green, consists of a 151kb probe distal to the NUP98 gene, covering the ZNF195 gene and the D11S4731 marker. Fluorescence in situ hybridisation (FISH) is a technique that allows the visualisation of DNA sequences upon chromosomes.
Product code: MVU Reagents, Specific, Analyte
Reason for recall: A low risk of a false positive result being issued with a laboratory developed test (LDT) that utilizes the LPH533-A NUP98 Distal Probe Green.
FDA root cause: Under Investigation by firm
Action: Cytocell issued Urgent Medical Device Recall Letter dated July 17,200 stating reason for recall, health risk and action to take: Immediately examine your inventory and quarantine all product subject to recall. Cytocell requests that you destroy the remaining inventory. Please complete and return the enclosed response form as soon as possible. We wish to sincerely apologise for any inconvenience caused as a result of this medical device recall. If you have any questions, contact Cytocell on Tel: +44 (0)1223 294048, Fax +44(0)1223 294986 or [email protected].
Quantity in commerce: 62 units
Distribution: Worldwide distribution - US Nationwide distribution and the country of Canada.
Product codes and lots: Lot numbers: 069915, 070433, 069305, 069468

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2829-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2829-2020	Class II	Terminated	Voluntary: Firm initiated	2020-08-26	2020-08-20

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)