FDA Medical Device Recalls (openFDA)
Trek Diagnostic Systems: VersaTREK Myco AS.
- Recall number
- Z-1540-05
- Recalling firm
- Trek Diagnostic Systems
- Product
- VersaTREK Myco AS.
- Status
- Terminated
- Initiated
- 2005-08-08
- Posted
- 2005-09-14
- Terminated
- 2007-07-21
- 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.
- Lot, serial or model codes
- lot code 144365, expiration date 2005/11.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MDB
- Firm FEI
- 1000515493
- Firm city
- Cleveland
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28