Recall Z-1816-2010 ยท GHC Tube, Sedimentation Rate
Vital Diagnostics, Inc.
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.
| Date | Jun 22, 2010 (initiated Apr 12, 2010) |
| Status | Terminated |
| Reason | The tube may fall out or separate from the Slider adapter |
| 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 | 4,723 units |
| Distribution | Distributed Nationwide and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.