Device product
R&D systems, a bio-techne brand Human Total 25-OH Vitamin D IVD ELISA Kit, REF RDKAP1971
Z-0410-2019
Product summary
- Event
- Event 81121
- Status
- Terminated
- Classification
- Class III
- Quantity
- 8 kits
- Official record key
device-enforcement:Z-0410-2019
Official wording
Reason: The kit was provided without a copy of the lot-specific kit booklet and the Calibrator 0 vial 18D1/4 label incorrectly specified reconstitution volume of 2mL.
Code information: Manufacturing Lot # 182801
Distribution pattern: IA and CO
Derived failure modes
-
Unknown
The kit was provided without a copy of the lot-specific kit booklet and the Calibrator 0 vial 18D1/4 label incorrectly specified reconstitution volume of 2mL.