R&D systems, a bio-techne brand Human Total 25-OH Vitamin D IVD ELISA Kit, REF RDKAP1971
Reported: November 14, 2018 Initiated: September 11, 2018 #Z-0410-2019
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.
Details
- Recalling Firm
- R & D Systems, Inc.
- Units Affected
- 8 kits
- Distribution
- IA and CO
- Location
- Minneapolis, MN
Frequently Asked Questions
What product was recalled? ▼
R&D systems, a bio-techne brand Human Total 25-OH Vitamin D IVD ELISA Kit, REF RDKAP1971. Recalled by R & D Systems, Inc.. Units affected: 8 kits.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 14, 2018. Severity: Low. Recall number: Z-0410-2019.
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