FDA Medical Device Recalls (openFDA)
Cytocell Ltd.: Del(5q) Deletion FISH Probe Kit: In-Vitro Diagnostic to detect deletions in chromosome location from patients with AML or MDS Catalog Number: USA-LPH024
- Recall number
- Z-0741-2022
- Recalling firm
- Cytocell Ltd.
- Product
- Del(5q) Deletion FISH Probe Kit: In-Vitro Diagnostic to detect deletions in chromosome location from patients with AML or MDS Catalog Number: USA-LPH024
- Status
- Terminated
- Initiated
- 2022-01-18
- Posted
- not on file
- Terminated
- 2024-11-08
- Reason
- individual components have been labelled with incorrect colours. The red and green colours are opposite to those specified in the product labelling. The EGR1 probe is labelled in green rather than red and the control probe labelled in red rather than green. The expected positive signal pattern in the case of 1x deleted 5q will be 1G2R instead of 1R2G, an incorrect result
- Root cause
- Software Manufacturing/Software Deployment
- Action
- Cytocell issued Urgent Medical Recall Reference: VC/2022/001 letter on 1/18/22 to Distributors and End Users via email. 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 any results obtained with the affected devices and check that signal patterns were not misinterpreted as a result of the probe being manufactured with the fluorophores the incorrect way around. 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 vigilance@ogt.com.
- Quantity
- 19 kits
- Distribution
- US Nationwide distribution in the states of Hawaii, Missouri, Pennsylvania, Tennessee.
- Lot, serial or model codes
- Lot Number: 075711 Exp. Date: 2023-06-22 UDI: (01)05055844901551(17)230622(10)075 711
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- QDI
- 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