Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38 commonly used clinical chemistry tests.
Reported: May 15, 2024 Initiated: March 5, 2024 #Z-1759-2024
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.
Details
- Recalling Firm
- Randox Laboratories Ltd.
- Units Affected
- 80,366 units (US: 242 units; OUS: 80,094 units)
- Distribution
- Domestic: Nationwide Distribution.
- Location
- Crumlin (North), N/A
Frequently Asked Questions
What product was recalled? ▼
Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38 commonly used clinical chemistry tests.. Recalled by Randox Laboratories Ltd.. Units affected: 80,366 units (US: 242 units; OUS: 80,094 units).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 15, 2024. Severity: Moderate. Recall number: Z-1759-2024.
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