FDA Medical Device Recalls (openFDA)
Randox Laboratories Ltd.: This is an in vitro diagnostic product intended for use as a calibration serum in clinical chemistry assays. Randox calibration sera contain 42 analytes and are based on lyophilized human serum. The concentrations and activities are suitable for calibration of clinical chemistry assays both manually and on a wide range of automatic analyzers. Constituent concentrations are available at 2 levels.
- Recall number
- Z-2490-2019
- Recalling firm
- Randox Laboratories Ltd.
- Product
- This is an in vitro diagnostic product intended for use as a calibration serum in clinical chemistry assays. Randox calibration sera contain 42 analytes and are based on lyophilized human serum. The concentrations and activities are suitable for calibration of clinical chemistry assays both manually and on a wide range of automatic analyzers. Constituent concentrations are available at 2 levels.
- Status
- Terminated
- Initiated
- 2019-07-12
- Posted
- not on file
- Terminated
- 2020-06-17
- Reason
- Randox Laboratories realigned RX Analyser Series calibration targets by 10% for AST and 9% for ALT in line with the Mean of All Instrument method target for the Randox Calibration Serum Level 3 (for calibrator lot 961UE onwards).
- Root cause
- Under Investigation by firm
- Action
- Randox Laboratories Ltd. issued Urgent Medical Device Correction letter on 7/12/19 advising users of the problem, health risk and action to take: Replace all Quality Control value sheets with the revised sheets available on www.randox.com . Discuss the contents of this notice with your Medical Director. Complete and return the response form 12187-QA to technical.services@randox.com within five working days.
- Quantity
- 307 kits
- Distribution
- Nationwide Foreign: Antigua, Aruba, Bahamas, Granada, Tobago,
- Lot, serial or model codes
- Lot Numbers: 961UE onwards GTN: 05055273200966
- 510(k) numbers
- K053153
- 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
- 3e6df46828c1
- Size
- 288213574 bytes
- Published
- 2026-10-06
- Read
- 2026-10-07T03:20:25.099Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-14
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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 3e6df46828c1, published 2026-10-06