IDS-iSYS Intact PINP Control Set, Catalog Number IS-4030. Packaged in cardboard Box containing plastic bottles. The IDS-

FDA device recall Z-0045-2013 · posted 2012-10-10 · Terminated

Recall details

Recalling firm

Immunodiagnostics Systems Ltd

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.

Action taken

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.

Root cause

Labeling False and Misleading

Status

Terminated

Product code

JIT

Quantity affected

29

Distribution

Nationwide Distribution including NY, CA, ME and CT.

Date initiated

2012-08-10

Date posted

2012-10-10

Date terminated

2012-12-17

Location

Boldon Tyne & Wear, United Kingdom