Excyte Slider Barcode Tube Adapter used with Excyte Vacuum or Non-Vacuum ESR Tubes. Single Use. Product Number: EX-I0552

FDA device recall Z-1816-2010 · posted 2010-06-22 · Terminated

Recall details

Recalling firm

Vital Diagnostics, Inc.

Reason for recall

The tube may fall out or separate from the Slider adapter

Action taken

Vital Diagnostics issued recall letter dated April 14, 2010 via Certified Mail in an envelop marked "Urgent Recall Information Inside", requesting accounts to discontinue use and destroy recalled product. A Certificate of Destruction and Refund Form was included to direct customers. A second Distributor Notice was sent by email to the distributors with Important Recall Information in the title. This was accompanied with the same Technical Bulletin, Certificate of Destruction and Refund Form. For further information, contact Vital Diagnostics at 1-800-345-2822.

Root cause

Component change control

Status

Terminated

Product code

GHC

Quantity affected

4,723 units

Distribution

Distributed Nationwide and Canada.

Date initiated

2010-04-12

Date posted

2010-06-22

Date terminated

2010-09-13

Location

Lincoln, RI