Recall Z-0039-2013 ยท JMM Column Chromatography & Color Development, Hydroxyproline
Immunodiagnostics Systems Ltd
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 re
| Date | Oct 10, 2012 (initiated Aug 10, 2012) |
| Status | Terminated |
| Reason | 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 | 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 immediatel |
| Quantity | 1 |
| Distribution | Nationwide Distribution including NY, CA, ME and CT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.