Hemochron Signature Elite Whole Blood Microcoagulation (IVD) System. The system is intended to be used only with test cu

FDA device recall Z-0893-2011 · posted 2011-03-01 · Terminated

Recall details

Recalling firm

International Technidyne Corp.

Reason for recall

There is a mismatch between the class of the laser barcode scanner and the labeling of the Hemochron Signature Elite: some of the devices were inadvertently equipped with class II laser barcode scanner instead of the intended class I barcode scanner.

Action taken

Urgent - Medical Device Recall - Hemochron Signature Elite letters, dated February 24, 2010, by Federal Express to all direct customers. The letter informed customers of the issue and stated that the problem does not negatively affect the performance of the product and to continue using the product as intended. In addition, customers are to notify the appropriate personnel about the notice, complete and return the attached form, and an ITC representative will contact customers to discuss arrangements to re-label their devices. Customers can contact ITC Technical Support at 800-579-2255 (US) or 732-548-5700 ext 4700 (International) if they have any questions regarding this issue and notice. Customers can also email sigelitescan@itcmed.com with questions.

Root cause

Labeling mix-ups

Status

Terminated

Product code

RFZ

Quantity affected

1640 units (1303 US, 337 foreign)

Distribution

Worldwide Distribution -- United Arab Emirates, Belgium, Canada, Switzerland, Germany, Denmark, France, United Kingdom, Ireland, Iceland, Italy, Kuwait, Liechtenstein, Netherlands, Oman, Qatar, Saudi

Date initiated

2010-03-31

Date posted

2011-03-01

Date terminated

2012-09-25

Location

Edison, NJ