Reported Jan 23, 2013 · Terminated

25-Hydroxy Vitamin D EIA, Catalog #AC-57F1. Product Usage: The IDS 25-Hydroxy Vitamin D EIA kit is an enzymeimmunoassay…

IDS (Immunodiagnostic Systems Ltd.)

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: IDS (Immunodiagnostic Systems Ltd.) · Usworth Hall · Washington, N/A · N/A

Is this the product you have?

    • 25-Hydroxy Vitamin D EIA
    • Catalog #AC-57F1
  • Product UsageThe 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
Lot codes and dates
  • Lot # 17628
Amount recalled
675 units

Where it was sold

  • Nationwide

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated May 31, 2013 · Data as of Sep 19, 5:26 PM UTC

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