Recall Z-1540-05 ยท MDB System, Blood Culturing
Trek Diagnostic Systems
VersaTREK Myco AS.
| Date | Sep 14, 2005 (initiated Aug 8, 2005) |
| Status | Terminated |
| Reason | Invitro diagnostic test kit used for testing to confirm the presence of tuberculosis contains interfering bioburden which can cause false positive results. |
| Root cause | Other |
| Action | The recalling firm phoned all 13 consignees that the product was distributed to, and sent a recall letter to all 13 consignees, dated August 8, 2005. All 13 consignees have responded back to the recalling firm and have discarded any remaining product that was on hand. |
| Quantity | 29 boxes containing 5 vials in each box. |
| Distribution | The product was distributed to consignees located in AL, IA, IL, MD, NJ, OH, PA, Washington D.C. and to two foreign distributors: I.L. Diagnostics, Lago Victoria No. 80, Col. Granada, Mexico D.F., 11520; and Trivitron Diagnostics, #15 4th Street, Abhiramapuram, Chennai, India 600-018. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.