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Terminated

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

FDA Recall Z-0472-06 · Posted 2006-02-04

Recalling FirmTeco Diagnostics
Recall StatusTerminated
Product CodeKQO
Date Initiated2005-12-22
Date Terminated2012-03-07
Product Quantity50

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.

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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