FDA Medical Device Recalls (openFDA)
Cytocell Ltd.: CytoCell DiGeorge/VCFS TUPLE1 Region and 22q13.3 Region Probe, Model Number LPU004-A. analyte specific reagent for in vitro diagnostics
- Recall number
- Z-2134-2021
- Recalling firm
- Cytocell Ltd.
- Product
- CytoCell DiGeorge/VCFS TUPLE1 Region and 22q13.3 Region Probe, Model Number LPU004-A. analyte specific reagent for in vitro diagnostics
- Status
- Terminated
- Initiated
- 2021-05-17
- Posted
- not on file
- Terminated
- 2022-08-15
- Reason
- 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
- 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 vigilance@ogt.com.
- Quantity
- 50
- Distribution
- Distribution to US states of CA, IL, MO, NY, PA, TX, and UT, and Canada.
- Lot, serial or model codes
- Lot Numbers: 071399 072985
- 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