ImmunoDOT Autoimmunity Panel 4
GenBio · Model 800-5425 · UDI-DI 00613745054254
10
510(k) clearances
1
Adverse events
4
Recalls
25
Facilities
Description
The ImmunoDOT Autoimmunity Screening Panel 4 is an enzyme immunoassay (EIA) test for screening and detection of autoantibodies against various specific nuclear antigens in serum and heparinized whole blood and used as an aid in the diagnosis of autoimmune disorders. This product is intended for use in physician offices and clinical laboratories.
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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