Device product
Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38 commonly used clinical chemistry tests.
Z-1759-2024
Product summary
- Event
- Event 94358
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 80,366 units (US: 242 units; OUS: 80,094 units)
- Official record key
device-enforcement:Z-1759-2024
Official wording
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.
Code information: Catalogue No. CAL2351 & CAL10388; GTIN: 05055273200966; Lot No. 1260UE, 1262UE, 1295UE, 1297UE, 1298UE, 1315UE, 1325UE, 1326UE, 1295UE, & 1325UE.
Distribution pattern: Domestic: Nationwide Distribution.
Derived failure modes
-
Unknown
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.