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U.S. Department of Health and Human Services

Class 2 Device Recall IDS

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 Class 2 Recall
IDS
see related information
Date Posted January 18, 2013
Recall Status1 Terminated on May 31, 2013
Recall Number Z-0697-2013
Recall Event ID 63840
Premarket Notification
510(K) Number
K021163 
Product Classification System, Test, Vitamin D - Product Code MRG
Product 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.
Code Information Lot # 17628
Recalling Firm/
Manufacturer
IDS (Immunodiagnostic Systems Ltd.)
Usworth Hall
Washington
Consumer Instructions Contact the recalling firm for information
Manufacturer 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.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
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.
Quantity in Commerce 675 units
Distribution US Nationwide Distribution
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MRG and Original Applicant = IMMUNODIAGNOSTIC SYSTEMS LTD.
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