Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38 commonly used clinical chemistry tests.
FDA Recall Z-1759-2024 · Posted 2024-05-03
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Recalling FirmRandox Laboratories Ltd.
Recall StatusOpen, Classified
Product CodeJIX
Date Initiated2024-03-05
Product Quantity80,366 units (US: 242 units; OUS: 80,094 units)
Reason for Recall
Randox Laboratories has identified that Inorganic Phosphate in Calibration Serum Level 3, CAL2351 & CAL10388, is running with a negative bias on RX Series instruments compared to other methods.
Firm Action
Consignees were emailed a Medical Device Correction notice dated 3/5/2024 instructing them to discuss the contents of the notification with their facility's Medical Director if affected units have been used, replace the IFU for affected devices with the one provided with the notification, and complete and return the provided response form by email to technical [email protected] within five working days. Updated IFUs can be accessed at www.randox.com and questions can be directed to [email protected].
Root Cause
Process design
Distribution Pattern
Domestic: Nationwide Distribution.
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.
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