Excyte Slider Barcode Tube Adapter used with Excyte Vacuum or Non-Vacuum ESR Tubes. Single Use. Product Number: EX-I0552. Manufactured by Vital Diagnostics S.R.L., Italy. Slider allows a larger label to be applied to the ESR tube.
FDA Recall Z-1816-2010 · Posted 2010-06-22
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Recalling FirmVital Diagnostics, Inc.
Recall StatusTerminated
Product CodeGHC
Date Initiated2010-04-12
Date Terminated2010-09-13
Product Quantity4,723 units
Reason for Recall
The tube may fall out or separate from the Slider adapter
Firm Action
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
Distribution Pattern
Distributed Nationwide and Canada.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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