FDA Medical Device Recalls (openFDA)
Teco Diagnostics: Uritek TC-101Urine Analyzer, catalog number TC-101
- Recall number
- Z-0472-06
- Recalling firm
- Teco Diagnostics
- Product
- Uritek TC-101Urine Analyzer, catalog number TC-101
- Status
- Terminated
- Initiated
- 2005-12-22
- Posted
- 2006-02-04
- Terminated
- 2012-03-07
- Reason
- When reading the Nitrite parameter on the Teco Diagnostics URS-10 strips, some positive nitrite samples may be read by the machine as negative.
- Root cause
- Other
- Action
- On December 22nd,2005 the firm sent the notification letter along with a replacement unit of TC-101. These letters and replacement units were send via Fed ex ground and the tracking numbers and serial numbers of the sent units are also noted. Also noted are the return authorization numbers assigned to each respective customer.
- Quantity
- 50
- Distribution
- Nationwide
- Lot, serial or model codes
- Serial# 200509001 through 200509050
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KQO
- Firm FEI
- 1832216
- Firm city
- Anaheim
- Firm state
- CA
- 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