FDA Medical Device Recalls (openFDA)
R & D Systems, Inc.: R&D systems, a bio-techne brand Human Total 25-OH Vitamin D IVD ELISA Kit, REF RDKAP1971
- Recall number
- Z-0410-2019
- Recalling firm
- R & D Systems, Inc.
- Product
- R&D systems, a bio-techne brand Human Total 25-OH Vitamin D IVD ELISA Kit, REF RDKAP1971
- Status
- Terminated
- Initiated
- 2018-09-11
- Posted
- not on file
- Terminated
- 2020-09-01
- 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.
- Root cause
- Unknown/Undetermined by firm
- Action
- 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.
- Quantity
- 8 kits
- Distribution
- IA and CO
- Lot, serial or model codes
- Manufacturing Lot # 182801
- 510(k) numbers
- K123364
- PMA numbers
- not on file
- Product code
- MRG
- Firm FEI
- 2182501
- Firm city
- Minneapolis
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28