Device product
Randox Urinalysis Control Level 2 (IVD) Ref: UC5034 - Product Usage: Product is intended for in vitro diagnostic use in the quality control of urine test strips.
Z-2557-2019
Product summary
- Event
- Event 83592
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1 kit
- Official record key
device-enforcement:Z-2557-2019
Official wording
Reason: Analyte range for Leukocytes for use with the Siemens Multistix method is incorrect. The range was corrected to NEGATIVE to 3+.
Code information: Lot: 1020UC Exp. Date: 28 May 2020
Distribution pattern: US Nationwide distribution including the states of IN, WV.
Derived failure modes
-
Unknown
Analyte range for Leukocytes for use with the Siemens Multistix method is incorrect. The range was corrected to NEGATIVE to 3+.