Recall Z-0697-2013— IDS (Immunodiagnostic Systems Ltd.)

Name: FDA recall Z-0697-2013
Creator: U.S. Food and Drug Administration
Published: 2012-11-07

Class II · Terminated

Class II FDA medical device recall by IDS (Immunodiagnostic Systems Ltd.), initiated 2012-11-07, terminated 2013-05-31. It names one FDA 510(k) clearance: K021163. 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.. Reason: 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..

Recalling firm: IDS (Immunodiagnostic Systems Ltd.)
Classification: Class II
Status: Terminated
Initiated: 2012-11-07
Terminated: 2013-05-31
Firm location: Washington, N/A, United Kingdom

510(k) clearances named in this recall

1 on FDA's record

K021163 — OCTEIA 25-HYDROXY VITAMIN DImmunodiagnostic Systems , Ltd.·cleared 2002-05-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.