R&D Systems recalls Human Total 25-OH Vitamin D IVD ELISA Kit (REF RDKAP1971) due to missing lot-specific manual and incorrect reconstitution volume label. Affected units sold with Manufacturing Lot # 182801.
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.
R&D Systems is recalling a Human Total 25-OH Vitamin D IVD EL:ISA Kit (REF RDKAP1971) because it was shipped without the lot-specific kit booklet and the Calibrator 0 vial label incorrectly states a 2mL reconstitution volume. This could lead to inaccurate test results if users follow the wrong instructions.
The kit lacks the lot-specific booklet needed for proper use, and the Calibrator 0 vial label incorrectly states a 2mL reconstitution volume. This could cause inaccurate vitamin D test results if users follow the wrong instructions.
People who purchased the Human Total 25-OH Vitamin D IVD ELISA Kit (REF RDKAP1971) with Manufacturing Lot # 182801 from R&D Systems. Laboratory users and healthcare professionals are most at risk of inaccurate test results.
Check for the product name 'Human Total 25-OH Vitamin D IVD ELISA Kit' with reference number RDKAP1971 and Manufacturing Lot # 182801. The kit was sold by R&D Systems.
Verify if the kit includes the lot-specific booklet and the Calibrator 0 vial label correctly states the reconstitution volume.
The kit was shipped without the lot-specific booklet and the Calibrator 0 vial label incorrectly states a 2mL reconstitution volume.
Check if the kit includes the lot-specific booklet and verify the Calibrator 0 vial label shows the correct reconstitution volume.
The recall record does not mention a remedy or fix.
We’ve drafted a message you can send R&D Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-0410-2019 — R&D Systems R&D Systems Hello, I own a R&D Systems that is covered by recall Z-0410-2019 from R&D Systems. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
