Uritek TC-101Urine Analyzer, catalog number TC-101
FDA device recall Z-0472-06 · posted 2006-02-04 · Terminated
Recall details
- Recalling firm
- Teco Diagnostics
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- KQO
- Quantity affected
- 50
- Distribution
- Nationwide
- Date initiated
- 2005-12-22
- Date posted
- 2006-02-04
- Date terminated
- 2012-03-07
- Location
- Anaheim, CA
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