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QMedix™
Diagnostic Automation, Inc. · Model DACD3149-15 · UDI-DI 00850054026484
10
510(k) clearances
100
Adverse events
1
Recalls
13
Facilities
Description
QMedix™T4 ELISA kit is intended to be used to quantitatively measure total thyroxine (TT4) in a clinical specimen, using an enzyme immunoassay (EIA) method.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-06-04 | DRG International, Inc. | An incoming complaint reported that the expiration date on the kit box label and Certificate of Analysis (CoA) exceeded the shelf life of the standards and control solutions in the |
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