FDA Medical Device Recalls (openFDA)
Cytocell Ltd.: Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's)
- Recall number
- Z-2323-2021
- Recalling firm
- Cytocell Ltd.
- Product
- Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's)
- Status
- Terminated
- Initiated
- 2021-05-27
- Posted
- not on file
- Terminated
- 2022-05-09
- Reason
- 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
- 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 vigilance@ogt.com.
- Quantity
- 23 units
- Distribution
- US Nationwide distribution in the states of CA, IL, KY, NY, OH, TX, UT, VA.
- Lot, serial or model codes
- Lots 073004 and 072518 (Probe lot 200918-006).
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MVU
- Firm FEI
- 3002646096
- Firm city
- Cambridge
- Firm state
- not on file
- Firm country
- United Kingdom
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28