Recall Z-1759-2024— Randox Laboratories Ltd.
Class II · Ongoing
Class II FDA medical device recall by Randox Laboratories Ltd., initiated 2024-03-05. It names one FDA 510(k) clearance: K053153. Product: Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38 commonly used clinical chemistry tests.. Reason: 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..
- Recalling firm
- Randox Laboratories Ltd.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-03-05
- Firm location
- Crumlin (North), N/A, Ireland
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38 commonly used clinical chemistry tests.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.