FDA Medical Device Recalls (openFDA)
Randox Laboratories Ltd.: SP CAL (LIQ), REF IT2692 This product is intended for in vitro diagnostic use with Randox Alpha-1-Antitrypsin, Alpha-1-Acid Glycoprotein, IgA, IgG and IgM assays that require sample predilution.
- Recall number
- Z-0660-2019
- Recalling firm
- Randox Laboratories Ltd.
- Product
- SP CAL (LIQ), REF IT2692 This product is intended for in vitro diagnostic use with Randox Alpha-1-Antitrypsin, Alpha-1-Acid Glycoprotein, IgA, IgG and IgM assays that require sample predilution.
- Status
- Terminated
- Initiated
- 2018-11-19
- Posted
- not on file
- Terminated
- 2020-04-23
- Reason
- Calibrator value sheets have been modified for assigned value of Alpha-1-Acid-Glycoprotein (AGP), IgA and IgG to improve the alignment. IgG measurement reference has also been corrected.
- Root cause
- Under Investigation by firm
- Action
- On November 19, 2018, Randox Laboratories Ltd. issued "Urgent Medical Device Correction" notices and New Calibrator Value sheets (Revised 15 Nov 18 pl) to customers. Customers were advised to take the following action: - Review all remaining stock. Add the notice and replace the calibrator value sheet with the revised document provided. - Discuss the contents of the notice with your Medical Director. Review results generated with the affected batches in line with the clinical profile of the patient. - Retain a copy of the letter with laboratory records and forward a copy of the letter to those who may have received this product. - Return the completed response form via email to technical.services@randox.com. If you have any questions, contact RA Specialist by email at maria.kelly@randox.com.
- Quantity
- 250 kits (32 kits US / 218 kits OUS)
- Distribution
- US Distribution to states of : IN, NJ, NY, TX and WV and internationally to Ireland.
- Lot, serial or model codes
- 05055273204049 Lot Number: 415879 Date of Expiry - 28 March 2019
- 510(k) numbers
- ["K031608"]
- PMA numbers
- not on file
- Product code
- JIX
- 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
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