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Trinity Biotech
MARDX DIAGNOSTICS, INC. · Model 40-3020G · UDI-DI 05391516747844
10
510(k) clearances
1
Adverse events
4
Recalls
24
Facilities
Description
HEp-2 Marblot Strip Test System, Western Blot System for the detection of IgG antibody to human extractable nuclear antigens, 20 Tests
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2012-08-06 | Diamedix Corporation | Diamedix Corporation recalled their Is-anti-Sm Test Kit due to the Positive Control recovering high out of specification. |
| 2011-06-08 | Diamedix Corporation | On 06/08/2011 Diamedix Corporation initiated a recall of Is-ENA-6 Screen Test Kit, Catalog # 720-320 Master Lot S0000, Exp. Date May 31, 2012. The labeling on the kit box has an e |
| 2008-11-25 | Immuno Concepts Inc | In certain patient samples, it is difficult to properly discriminate between anti-Sm/RMP positive samples and samples that are only anti-Sm positive. |
| 2004-04-20 | Diasorin Inc. | An error in the Bio-Tek ELx800 microplate reader programming specifications for the ENA screen Assay exists in that an equivocal (borderline) zone is missing. |
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