Z-0697-2013 Class II Terminated
FDA device recall Z-0697-2013 was initiated by IDS (Immunodiagnostic Systems Ltd.) on November 7, 2012 and is designated Class II. 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 wa… The recall status is terminated (terminated May 31, 2013). Affected quantity: 675 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 23, 2013
- Initiation Date
- November 7, 2012
- Termination Date
- May 31, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 675 units
Product Description
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.
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.
Distribution Pattern
US Nationwide Distribution
Code Information
Lot # 17628