Z-0697-2013Class II

25-Hydroxy Vitamin D EIA, Catalog #AC-57F1

Name: Z-0697-2013 25-Hydroxy Vitamin D EIA, Catalog #AC-57F1
Creator: IDS (Immunodiagnostic Systems Ltd.)
Published: 2012-11-07
License: https://open.fda.gov/license/

IDS (Immunodiagnostic Systems Ltd.) / initiated 2012-11-07 / Terminated / root cause: manufacturing process

FDA source

IDS (Immunodiagnostic Systems Ltd.) began a recall of 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... on 2012-11-07. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0697-2013
Classification: Class II
Status: Terminated
Initiated: 2012-11-07
Posted: 2013-01-18
Terminated: 2013-05-31
Recalling firm: IDS (Immunodiagnostic Systems Ltd.)
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.
Product code: MRG System, Test, Vitamin D
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.
Root cause tag: manufacturing process
FDA root cause: 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
Product codes and lots: Lot # 17628

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0697-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0697-2013	Class II	Terminated	Voluntary: Firm initiated	2013-01-23	2013-01-17

Product code MRG

K021163Class IIOcteia 25-Hydroxy Vitamin DImmunodiagnostic Systems , Ltd. / cleared 2002-05-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)