FDA Medical Device Recalls (openFDA)
Randox Laboratories, Limited: Liquid Cardiac Control CQ5053
- Recall number
- Z-0937-2018
- Recalling firm
- Randox Laboratories, Limited
- Product
- Liquid Cardiac Control CQ5053
- Status
- Terminated
- Initiated
- 2017-08-08
- Posted
- not on file
- Terminated
- 2018-09-05
- Reason
- Randox has confirmed that Troponin T and Troponin I in Liquid Cardiac quality control CQ5053 lot 4069CK does not meet the shelf-life claim in the product labelling. As the control may now fall outside the provided control ranges the product is to be recalled from the field.
- Root cause
- Unknown/Undetermined by firm
- Action
- A recall notice was issued to customers on August 1, 2017 instructing them to discontinue use of product, discard remaining product for reimbursement and provide documentation of destruction.
- Quantity
- 450 kits
- Distribution
- Nationally
- Lot, serial or model codes
- Lot 4069CK
- 510(k) numbers
- ["K110534"]
- PMA numbers
- not on file
- Product code
- JJY
- Firm FEI
- 1000361607
- Firm city
- Crumlin
- 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