FDAFDA · Food and drugs·Recall number Z-0697-2013
25-Hydroxy Vitamin D EIA, Catalog #AC-57F1. Product Usage: The IDS 25-Hydroxy Vitamin D EIA kit is an enzymeimmunoassay intended for the quantitative determination of 25-hydroxyvitamin D (25-OH D) and other hydroxylated metabolites in human serum or plasma. Results are to be used in conjunction with other clinical and laboratory data to assist the clinician in the assessment of vitamin D sufficiency in adult populations.
Published January 23, 2013 · Recall initiated: November 7, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Immunodiagnostic Systems is recalling the 25-Hydroxy Vitamin D EIA, AC-57F1 because the QC report was found to have an erroneous calibrator value assigned. The value of 24.4 ng/mL for calibrator 4 was stated on the QC report, however the correct value should have read 28.4 ng/mL.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- IDS (Immunodiagnostic Systems Ltd.)
- Distributor
- US Nationwide Distribution
- Lot
- Lot # 17628
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United Kingdom
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