Recall Z-0410-2019
R & D Systems, Inc. · initiated September 11, 2018
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
R&D systems, a bio-techne brand Human Total 25-OH Vitamin D IVD ELISA Kit, REF RDKAP1971
Codes / lots: Manufacturing Lot # 182801
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.
FDA-determined cause: Unknown/Undetermined by firm
Action taken
The firm contacted the consignees (end users) by telephone on 09/11/2018 to alert them of the issue. The firm followed with an email on 09/21/2018 restating the issue and offering to replace any unused kits.
Details
- Recall number
- Z-0410-2019
- Initiated
- September 11, 2018
- Terminated
- September 1, 2020
- Product code
- MRG – System, Test, Vitamin D
- Quantity
- 8 kits
- Distribution
- IA and CO
- Recalling firm
- R & D Systems, Inc., Minneapolis, MN