Z-0410-2019 Class III Terminated
FDA device recall Z-0410-2019 was initiated by R & D Systems, Inc. on September 11, 2018 and is designated Class III. Reason for recall: 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. The recall status is terminated (terminated September 1, 2020). Affected quantity: 8 kits.
Recall Details
- Product Type
- Devices
- Report Date
- November 14, 2018
- Initiation Date
- September 11, 2018
- Termination Date
- September 1, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8 kits
Product Description
R&D systems, a bio-techne brand Human Total 25-OH Vitamin D IVD ELISA Kit, REF RDKAP1971
Reason for Recall
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.
Distribution Pattern
IA and CO
Code Information
Manufacturing Lot # 182801