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Terminated

R&D systems, a bio-techne brand Human Total 25-OH Vitamin D IVD ELISA Kit, REF RDKAP1971

FDA Recall Z-0410-2019 · Posted None

Recalling FirmR & D Systems, Inc.
Recall StatusTerminated
Product CodeMRG
Date Initiated2018-09-11
Date Terminated2020-09-01
Product Quantity8 kits

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.

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.

Root Cause

Unknown/Undetermined by firm

Distribution Pattern

IA and CO

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K12336425OH VITAMIN D TOTAL ELISA TESTDiasource Immunoassays, S.A. · 2013-07-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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