Z-2323-2021Class II

Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's)

Name: Z-2323-2021 Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's)
Creator: Cytocell Ltd.
Published: 2021-05-27
License: https://open.fda.gov/license/

Cytocell Limited / initiated 2021-05-27 / Terminated / root cause: manufacturing process

FDA source

Cytocell Ltd. began a recall of Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's) on 2021-05-27. FDA classified it as Class II and gives the reason as "May show unexpected locus specific signals in addition to those at 19p13.3. Users may observe faint additional locus specific signals at 9q34". 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-2323-2021
Classification: Class II
Status: Terminated
Initiated: 2021-05-27
Posted: 2021-08-18
Terminated: 2022-05-09
Recalling firm: Cytocell Limited
Product: Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's)
Product code: MVU Reagents, Specific, Analyte
Reason for recall: May show unexpected locus specific signals in addition to those at 19p13.3. Users may observe faint additional locus specific signals at 9q34
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Cytocell issued Urgent Medical Device Recall Users issued via email on 5/27/21. Letter states reason for recall, heath 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 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 9q34. If you have any questions, contact Cytocell on Tel: +44 (0)1223 294048, Fax +44(0)1223 294986 or [email protected].
Quantity in commerce: 23 units
Distribution: US Nationwide distribution in the states of CA, IL, KY, NY, OH, TX, UT, VA.
Product codes and lots: Lots 073004 and 072518 (Probe lot 200918-006).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2323-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2323-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-25	2021-08-18

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)