Z-2134-2021Class II

CytoCell DiGeorge/VCFS TUPLE1 Region and 22q13.3 Region Probe, Model Number LPU004-A. analyte specific...

Name: Z-2134-2021 CytoCell DiGeorge/VCFS TUPLE1 Region and 22q13.3 Region Probe, Model Number LPU004-A. analyte specific...
Creator: Cytocell Ltd.
Published: 2021-05-17
License: https://open.fda.gov/license/

Cytocell Limited / initiated 2021-05-17 / Terminated / root cause: manufacturing process

FDA source

Cytocell Ltd. began a recall of CytoCell DiGeorge/VCFS TUPLE1 Region and 22q13.3 Region Probe, Model Number LPU004-A. analyte specific reagent for in vitro diagnostics on 2021-05-17. FDA classified it as Class II and gives the reason as "The device may show unexpected locus specific signals in addition to those at 22q. Users may observe faint additional locus specific signals at 20p12/13". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2134-2021
Classification: Class II
Status: Terminated
Initiated: 2021-05-17
Posted: 2021-07-23
Terminated: 2022-08-15
Recalling firm: Cytocell Limited
Product: CytoCell DiGeorge/VCFS TUPLE1 Region and 22q13.3 Region Probe, Model Number LPU004-A. analyte specific reagent for in vitro diagnostics
Product code: MVU Reagents, Specific, Analyte
Reason for recall: The device may show unexpected locus specific signals in addition to those at 22q. Users may observe faint additional locus specific signals at 20p12/13.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: An Urgent Medical Device Recall notification letter dated 5/17/21 was sent to customers. Actions to be taken by [Customer/User] 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 any results obtained with the affected devices and check that signal patterns were not misinterpreted as a result of any additional locus specific signal at 20p12/13. Corrective and Preventative Actions: Cytocell are currently investigating how this issue occurred and will be implementing the necessary corrective and preventative actions to reduce the risk of recurrence. Your assistance is appreciated and necessary to ensure the interpretation of a result from a resulting LDT is not affected. 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: 50
Distribution: Distribution to US states of CA, IL, MO, NY, PA, TX, and UT, and Canada.
Product codes and lots: Lot Numbers: 071399 072985

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2134-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2134-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-04	2021-07-23

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)