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Trinity Biotech
MARDX DIAGNOSTICS, INC. · Model B1029-70B · UDI-DI 05391516748841
1
510(k) clearances
9
Adverse events
4
Recalls
8
Facilities
Description
Toxi-Titer Diluent, 50 mL
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-09-22 | bioMerieux, Inc. | bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed result |
| 2007-12-04 | Biosite Inc | False Lower Results: Toxin A results in the Triage Micro C. difficile Panel have shown falsely lower visual signals (color strength) in certain lots compared to results observed wi |
| 2002-12-26 | Meridian Bioscience Inc | Due to defective packaging, the firm cannot assure product stability through the labeled expiration date. |
| 2002-12-26 | Meridian Bioscience Inc | Due to defective packaging, the firm cannot assure product stability through the labeled expiration date. |
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