Z-0039-2013Class II

IDS Urine BETA CrossLaps ELISA, Catalog Number AC-05F1. Type of packaging: Cardboard Box containing plastic...

Name: Z-0039-2013 IDS Urine BETA CrossLaps ELISA, Catalog Number AC-05F1. Type of packaging: Cardboard Box containing plastic...
Creator: Immunodiagnostics Systems Ltd
Published: 2012-08-10
License: https://open.fda.gov/license/

Immunodiagnostic Systems Ltd. / initiated 2012-08-10 / Terminated / root cause: labeling and UDI

FDA source

Immunodiagnostics Systems Ltd began a recall of IDS Urine BETA CrossLaps ELISA, Catalog Number AC-05F1. Type of packaging: Cardboard Box containing plastic bottles. The Urine BETA CrossLaps ELISA is an... on 2012-08-10. FDA classified it as Class II and gives the reason as "It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are labeled with IVD labels although they are not registered for sale as IVDs in the United States. The products should have...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0039-2013
Classification: Class II
Status: Terminated
Initiated: 2012-08-10
Posted: 2012-10-10
Terminated: 2012-12-17
Recalling firm: Immunodiagnostic Systems Ltd.
Product: IDS Urine BETA CrossLaps ELISA, Catalog Number AC-05F1. Type of packaging: Cardboard Box containing plastic bottles. The Urine BETA CrossLaps ELISA is an enzyme immunological test for the quantification of degradation products of C-terminal telopeptides of Type-I collagen in human urine. The Urine BETA CrossLaps ELISA assay is intended for in vitro diagnostic use as an indication of human bone resorption as an aid in A. Monitoring bone resorption changes of 1) Anti-resorptive therapies in postmenopausal women: a) Hormone Replacement Therapies (HRT) with hormones and hormone like drugs b) Bisphosphonate therapies B. Predicting skeletal response (Bone Mineral Density) in postmenopausal women undergoing anti-resorptive therapies a) Hormone Replacement Therapies (HRT) with hormones and hormone like drugs b) Bisphosphonate therapies
Product code: JMM Column Chromatography & Color Development, Hydroxyproline
Reason for recall: It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are labeled with IVD labels although they are not registered for sale as IVDs in the United States. The products should have been labeled as Research Use Only or Investigational use only dependent on their usage.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: Immunodiagnostics Systems sent Customer notification letters via email and notified customers of the recall. The notification included the reason for recall, product information with codes, lot number, manufacturing/distribution date, and exp date. The notification included instructions to customers: Actions to be taken by the customer: Customers should complete the attached Recall and Acknowledgement Form and take the following actions: 1) Check your stock for the products included within the scope of the recall. Cease use and distribution and quarantine all affected product lots immediately. 2) Complete the enclosed Recall & Acknowledgement Form and immediately fax back to Immunodiagnostic Systems. This will allow us to document your receipt of this letter and the amount of product you have on hand for return. 3) Return any affected product freight collect, along with the original completed Recall & Acknowledgement Form to your local IDS office. Contact information was also provided. For questions regarding this recall call +44 (191) 5195212.
Quantity in commerce: 1
Distribution: Nationwide Distribution including NY, CA, ME and CT.
Product codes and lots: Lot 14541, EXP Nov 2012

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0039-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0039-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-17	2012-10-10
Z-0040-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-17	2012-10-10
Z-0041-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-17	2012-10-10
Z-0042-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-17	2012-10-10
Z-0043-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-17	2012-10-10
Z-0044-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-17	2012-10-10
Z-0045-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-17	2012-10-10

Product code JMM

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)