R&D systems, a bio-techne brand Human Total 25-OH Vitamin D IVD ELISA Kit, REF RDKAP1971
- Company
- R & D Systems, Inc.
- Recall Initiated
- September 11, 2018
- Terminated
- September 1, 2020
- Recall Number
- Z-0410-2019
- Quantity
- 8 kits
- Firm Location
- Minneapolis, MN
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
IA and CO
Lot / Code Info
Manufacturing Lot # 182801
Root 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.
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