25-Hydroxy Vitamin D EIA, Catalog #AC-57F1. Product Usage: The IDS 25-Hydroxy Vitamin D EIA kit is an enzymeimmunoassay intended for ...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0697-2013.
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.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0697-2013.
Recall terminated by FDA.
🩺 Talk to your doctor or pharmacist
Product Recall Tracker does not provide medical advice. Any specific instructions about this medication or device come directly from the FDA notice above. Before making any change to your treatment:
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- Follow your clinician's guidance on whether to continue, switch, or return the product.
- If you have experienced a reaction, seek medical care and report it to the FDA via MedWatch.
- For the official FDA notice, visit the FDA recalls page.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0697-2013.
IDS (Immunodiagnostic Systems Ltd.)
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Ids (immunodiagnostic Systems Ltd.) Recall FAQ
Ids (immunodiagnostic Systems Ltd.) is the subject of a diagnostic devices safety report: 25-Hydroxy Vitamin D EIA, Catalog #AC-57F1. Product Usage: The IDS 25-Hydroxy Vitamin D EIA kit is an enzymeimmunoassay intended for .... The notice was published on November 7, 2012 by the U.S. Food and Drug Administration (FDA). Approximately 675 units are potentially affected.