Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

25-Hydroxy Vitamin D EIA Recalled by IDS (Immunodiagnostic Systems Ltd.) Due to Immunodiagnostic Systems is recalling the 25-Hydroxy Vitamin D...

Date: November 7, 2012
Company: IDS (Immunodiagnostic Systems Ltd.)
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact IDS (Immunodiagnostic Systems Ltd.) directly.

Affected Products

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.

Quantity: 675 units

Why Was This 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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About IDS (Immunodiagnostic Systems Ltd.)

IDS (Immunodiagnostic Systems Ltd.) has 1 total recall tracked by RecallDetector.

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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report