FDA Medical Device Recalls (openFDA)
Randox Laboratories Ltd.: Fructosamine Control 3, FR2996 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical chemistry systems.
- Recall number
- Z-1018-2019
- Recalling firm
- Randox Laboratories Ltd.
- Product
- Fructosamine Control 3, FR2996 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical chemistry systems.
- Status
- Open, Classified
- Initiated
- 2018-12-03
- Posted
- not on file
- Terminated
- not on file
- Reason
- The firm is conducting a Device Modification for Fructosamine Calibrator, Fructosamine Control 1 and Control 3 for the lots specified. The assigned value of Fructosamine in this calibrator and controls has now been re-assigned by a decrease of 25%.
- Root cause
- Under Investigation by firm
- Action
- The firm, Randox, notified the US distributor via email on 3 Dec 2018 with an "Urgent Medical Device Correction" letter dated 26 Nov 2018. The distributors and customers were instructed to remove the Value Sheet from existing stock and replace with the new Value Sheet and Important Notice. Customers were asked to take the following actions: " Please review all remaining stock and add the attached important notice to each kit. Replace the kit value sheet with the revised document provided. " Discuss the contents of this notice with your Medical Director. " Please retain this letter with your laboratory records and forward this letter to those who may have received this product. " Complete and return the response form to technical.services@randox.com within five working days. If you have any questions or concerns, please contact Randox Technical Services by email: maria.kelly@randox.com or +44 (0)28 9442 2413 or Tel: +1 304 728 2890 Toll Free 866 4 RANDOX or Email: Cheryl.O'Hagan@randox.com.
- Quantity
- 133 kits
- Distribution
- US Distribution to states to: CA, ME. MI, and WV.
- Lot, serial or model codes
- 500FR
- 510(k) numbers
- ["K023763"]
- PMA numbers
- not on file
- Product code
- JJX
- Firm FEI
- 1000361607
- Firm city
- Crumlin
- Firm state
- North
- Firm country
- Ireland
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
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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