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.
FDA Recall Z-2490-2019 · Posted None
Advertisement
Recalling FirmRandox Laboratories Ltd.
Recall StatusTerminated
Product CodeJIX
Date Initiated2019-07-12
Date Terminated2020-06-17
Product Quantity307 kits
Reason for Recall
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).
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 [email protected] within five working days.
Root Cause
Under Investigation by firm
Distribution Pattern
Nationwide Foreign: Antigua, Aruba, Bahamas, Granada, Tobago,
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement