Recall Z-0472-06 ยท KQO Automated Urinalysis System
Teco Diagnostics
Uritek TC-101Urine Analyzer, catalog number TC-101
| Date | Feb 4, 2006 (initiated Dec 22, 2005) |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.