Z-0741-2022Class II

Del(5q) Deletion FISH Probe Kit: In-Vitro Diagnostic to detect deletions in chromosome location from patients...

Name: Z-0741-2022 Del(5q) Deletion FISH Probe Kit: In-Vitro Diagnostic to detect deletions in chromosome location from patients...
Creator: Cytocell Ltd.
Published: 2022-01-18
License: https://open.fda.gov/license/

Cytocell Limited / initiated 2022-01-18 / Terminated / root cause: software

FDA source

Cytocell Ltd. began a recall of Del(5q) Deletion FISH Probe Kit: In-Vitro Diagnostic to detect deletions in chromosome location from patients with AML or MDS Catalog Number: USA-LPH024 on 2022-01-18. FDA classified it as Class II and gives the reason as "individual components have been labelled with incorrect colours. The red and green colours are opposite to those specified in the product labelling. The EGR1 probe is labelled in green rather than red and the control...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0741-2022
Classification: Class II
Status: Terminated
Initiated: 2022-01-18
Posted: 2022-03-09
Terminated: 2024-11-08
Recalling firm: Cytocell Limited
Product: Del(5q) Deletion FISH Probe Kit: In-Vitro Diagnostic to detect deletions in chromosome location from patients with AML or MDS Catalog Number: USA-LPH024
Product code: QDI Fish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies
Reason for recall: individual components have been labelled with incorrect colours. The red and green colours are opposite to those specified in the product labelling. The EGR1 probe is labelled in green rather than red and the control probe labelled in red rather than green. The expected positive signal pattern in the case of 1x deleted 5q will be 1G2R instead of 1R2G, an incorrect result
Root cause tag: software
FDA root cause: Software Manufacturing/Software Deployment
Action: Cytocell issued Urgent Medical Recall Reference: VC/2022/001 letter on 1/18/22 to Distributors and End Users via email. Letter states 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. We also suggest that laboratories undertake a review of any results obtained with the affected devices and check that signal patterns were not misinterpreted as a result of the probe being manufactured with the fluorophores the incorrect way around. Please complete and return the enclosed response form as soon as possible. If you have any questions, contact Cytocell on Tel: +44 (0)1223 294048, Fax +44(0)1223 294986 or [email protected].
Quantity in commerce: 19 kits
Distribution: US Nationwide distribution in the states of Hawaii, Missouri, Pennsylvania, Tennessee.
Product codes and lots: Lot Number: 075711 Exp. Date: 2023-06-22 UDI: (01)05055844901551(17)230622(10)075 711

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0741-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0741-2022	Class II	Terminated	Voluntary: Firm initiated	2022-03-16	2022-03-09

Product code QDI

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)