VersaTREK Myco AS.
FDA device recall Z-1540-05 · posted 2005-09-14 · Terminated
Recall details
- Recalling firm
- Trek Diagnostic Systems
- Reason for recall
- Invitro diagnostic test kit used for testing to confirm the presence of tuberculosis contains interfering bioburden which can cause false positive results.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- MDB
- Quantity affected
- 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., 115
- Date initiated
- 2005-08-08
- Date posted
- 2005-09-14
- Date terminated
- 2007-07-21
- Location
- Cleveland, OH
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