Z-1540-05

VersaTREK Myco AS

Name: Z-1540-05 VersaTREK Myco AS
Creator: Trek Diagnostic Systems
Published: 2005-08-08
License: https://open.fda.gov/license/

Trek Diagnostic Systems, Ltd. / initiated 2005-08-08 / Terminated / root cause: sterility

FDA source

Trek Diagnostic Systems began a recall of VersaTREK Myco AS on 2005-08-08. The reason FDA records is "Invitro diagnostic test kit used for testing to confirm the presence of tuberculosis contains interfering bioburden which can cause false positive results". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1540-05
Status: Terminated
Initiated: 2005-08-08
Posted: 2005-09-14
Terminated: 2007-07-21
Recalling firm: Trek Diagnostic Systems, Ltd.
Product: VersaTREK Myco AS.
Product code: MDB System, Blood Culturing
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.
Root cause tag: sterility
FDA 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 in commerce: 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.
Product codes and lots: lot code 144365, expiration date 2005/11.

Product code MDB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)