CLASS III Device recall · Reported 14 Nov 2018 · FDA Enforcement Report
a bio-techne Human Total 25-OH Vitamin D IVD Elisa Kit recalled
R & D Systems is recalling R&D systems, a bio-techne brand Human Total 25-OH Vitamin D IVD Elisa Kit, distributed in Colorado, Iowa. The recall was initiated on 11 Sep 2018 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0410-2019
- FDA event ID
- 81121
- Recalling firm
- R & D Systems, Minneapolis, MN
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 11 Sep 2018
- FDA classified
- 8 Nov 2018
- Reported
- 14 Nov 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 11 Sep 2018 | Recall initiated by company | |
| 8 Nov 2018 | Classified by FDA | +58 days |
| 14 Nov 2018 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
R&D systems, a bio-techne brand Human Total 25-OH Vitamin D IVD ELISA Kit, REF RDKAP1971
Where it was distributed
IA and CO
Questions about this recall
Is a bio-techne Human Total 25-OH Vitamin D IVD Elisa Kit recalled?
Yes. R & D Systems recalled a bio-techne Human Total 25-OH Vitamin D IVD Elisa Kit on 11 Sep 2018. The recall is Class III and its status is Terminated. Recall number Z-0410-2019.
Why was it 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 lots are affected?
Manufacturing Lot # 182801
Where was it sold?
IA and CO
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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