Medical Device
Manufacturing
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Z-1816-2010

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

ELITechGroup Inc / initiated 2010-04-12 / Terminated

Vital Diagnostics, Inc. began a recall of Excyte Slider Barcode Tube Adapter used with Excyte Vacuum or Non-Vacuum ESR Tubes. Single Use. Product Number: EX-I0552. Manufactured by Vital Diagnostics... on . The reason FDA records is "The tube may fall out or separate from the Slider adapter". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-1816-2010
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
ELITechGroup Inc
Product
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.
Product code
GHC Tube, Sedimentation Rate
Reason for recall
The tube may fall out or separate from the Slider adapter
FDA root cause
Component change control
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.
Quantity in commerce
4,723 units
Distribution
Distributed Nationwide and Canada.
Product codes and lots
All Lot Numbers