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.
FDA Recall Z-0697-2013 · Posted 2013-01-18
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Recalling FirmIDS (Immunodiagnostic Systems Ltd.)
Recall StatusTerminated
Product CodeMRG
Date Initiated2012-11-07
Date Terminated2013-05-31
Product Quantity675 units
Reason for Recall
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.
Firm Action
IDS sent a recall notification letter on November 7, 2012 to all customers that received the the 25-Hydroxy Vitamin D EIA (AC-57F1). The letter informed the customers of the problem identified and the action to be taken.
Customers are instructed to complete the attached Recall and Acknowledgement Form and fax back to Immunodiagnostic Systems Inc. Customers with questions are instructed to contact their local IDS office.
Root Cause
Nonconforming Material/Component
Distribution Pattern
US Nationwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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