Z-0472-06

Uritek TC-101Urine Analyzer, catalog number TC-101

Name: Z-0472-06 Uritek TC-101Urine Analyzer, catalog number TC-101
Creator: Teco Diagnostics
Published: 2005-12-22
License: https://open.fda.gov/license/

Teco Diagnostics / initiated 2005-12-22 / Terminated

FDA source

Teco Diagnostics began a recall of Uritek TC-101Urine Analyzer, catalog number TC-101 on 2005-12-22. The reason FDA records is "When reading the Nitrite parameter on the Teco Diagnostics URS-10 strips, some positive nitrite samples may be read by the machine as negative". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0472-06
Status: Terminated
Initiated: 2005-12-22
Posted: 2006-02-04
Terminated: 2012-03-07
Recalling firm: Teco Diagnostics
Product: Uritek TC-101Urine Analyzer, catalog number TC-101
Product code: KQO Automated Urinalysis System
Reason for recall: When reading the Nitrite parameter on the Teco Diagnostics URS-10 strips, some positive nitrite samples may be read by the machine as negative.
FDA 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 in commerce: 50
Distribution: Nationwide
Product codes and lots: Serial# 200509001 through 200509050

Product code KQO

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)