Z-0173-2009

IDS 25-Hydroxy Vitamin D EIA Enzymeimmunoassay for the quantitative determination of 25-hydroxyvitamin D and...

Name: Z-0173-2009 IDS 25-Hydroxy Vitamin D EIA Enzymeimmunoassay for the quantitative determination of 25-hydroxyvitamin D and...
Creator: Immunodiagnostics Systems Inc
Published: 2008-08-02
License: https://open.fda.gov/license/

Immunodiagnostic Systems Ltd. / initiated 2008-08-02 / Terminated / root cause: manufacturing process

FDA source

Immunodiagnostics Systems Inc began a recall of IDS 25-Hydroxy Vitamin D EIA Enzymeimmunoassay for the quantitative determination of 25-hydroxyvitamin D and other hydroxylated metabolites in serum or plasma... on 2008-08-02. The reason FDA records is "A small number of customers have experienced low absorbance values when using kits from this batch". 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-0173-2009
Status: Terminated
Initiated: 2008-08-02
Posted: 2008-10-24
Terminated: 2012-08-13
Recalling firm: Immunodiagnostic Systems Ltd.
Product: IDS 25-Hydroxy Vitamin D EIA Enzymeimmunoassay for the quantitative determination of 25-hydroxyvitamin D and other hydroxylated metabolites in serum or plasma. Ref: AC-57F1 Lot 60897 Exp 2009-08; Immunodiagnostic Systems Ltd, Unit 10, Boldon Business Park, Boldon, Tyne & Wear, NE35. 9PD, UK. Enzymeimmunoassay for the quantitative determination of 25-hydroxyvitamin D and other hydroxylated metabolites in serum or plasma
Product code: MRG System, Test, Vitamin D
Reason for recall: A small number of customers have experienced low absorbance values when using kits from this batch.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: All customers who received 25-Hydroxy Vitamin D EIA lot # 60897 were contacted by mail. Customers were instructed to sign a confirming document for having received the notification letter and return via fax. Customers are requested to contact Immunodiagnostic System Inc's office if they have any kits of 60897 remaining in stock. Rather than replacing only the biotin buffer as stated in the letter dated August 2, 2008, Immunodiagnostic Systems Inc. will replace the kit per the letter dated August 8, 2008. Contact Immunodiagnostic System Inc. at 1-480-836-7435 for assistance.
Quantity in commerce: 691 kits
Distribution: Nationwide
Product codes and lots: Lot Code #60897

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)