Trek Diagnostic Systems VersaTREK Myco AS. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
VersaTREK Myco AS.
Brand
Trek Diagnostic Systems
Lot Codes / Batch Numbers
lot code 144365, expiration date 2005/11.
Products Sold
lot code 144365, expiration date 2005/11.
Trek Diagnostic Systems is recalling VersaTREK Myco AS. due to Invitro diagnostic test kit used for testing to confirm the presence of tuberculosis contains interfering bioburden which can cause false positive res. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Invitro diagnostic test kit used for testing to confirm the presence of tuberculosis contains interfering bioburden which can cause false positive results.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, IL, IN, IA, MD, NJ, OH, PA, WA
Page updated: Jan 10, 2026