Z-0814-2022Class III

TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a technique allows the visualisation of...

Name: Z-0814-2022 TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a technique allows the visualisation of...
Creator: Cytocell Ltd.
Published: 2022-02-04
License: https://open.fda.gov/license/

Cytocell Limited / initiated 2022-02-04 / Terminated

FDA source

Cytocell Ltd. began a recall of TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a technique allows the visualisation of DNA sequences upon chromosome Catalog Number... on 2022-02-04. FDA classified it as Class III and gives the reason as "May show unexpected locus specific signals in addition to those at 14q32". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0814-2022
Classification: Class III
Status: Terminated
Initiated: 2022-02-04
Posted: 2022-03-21
Terminated: 2024-11-06
Recalling firm: Cytocell Limited
Product: TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a technique allows the visualisation of DNA sequences upon chromosome Catalog Number: LPH046-A
Product code: MVU Reagents, Specific, Analyte
Reason for recall: May show unexpected locus specific signals in addition to those at 14q32.
FDA root cause: Under Investigation by firm
Action: Cytocell issued Urgent Medical Device Recall letter (VC/2022/005) to Distributor/End User via email on 2/4/22 . 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 the results obtained with the affected devices and check that signal patterns were not misinterpreted as a result of any additional locus specific signals at 9q34. 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: 1 unit
Distribution: MN
Product codes and lots: Lot 074612

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0814-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0814-2022	Class III	Terminated	Voluntary: Firm initiated	2022-03-30	2022-03-21

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)