FDA Medical Device Recalls (openFDA)
Cytocell Ltd.: Aquarius CSF1R/RPS14 (5q32-q33) Probe Red, Model LPH540-A Analyte specific reagent.
- Recall number
- Z-1202-2019
- Recalling firm
- Cytocell Ltd.
- Product
- Aquarius CSF1R/RPS14 (5q32-q33) Probe Red, Model LPH540-A Analyte specific reagent.
- Status
- Terminated
- Initiated
- 2019-03-15
- Posted
- not on file
- Terminated
- 2020-10-13
- Reason
- There is an error in the chromomap included in the labeling for the product.
- Root cause
- Labeling Change Control
- Action
- Urgent Medical Device Recall notification letters dated 3/15/19 were sent to customers.
- Quantity
- 19
- Distribution
- The products were distributed to the following US states: IL, TN.
- Lot, serial or model codes
- Lot numbers: 056996 061156 062616 062808
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MVU
- Firm FEI
- 3002646096
- Firm city
- Banbury Oxfordshire
- 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