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ANA IFA: HEp-20-10
EUROIMMUN Medizinische Labordiagnostika AG · Model FA 1522-1050 · UDI-DI 04049016045366
1
510(k) clearances
1
Adverse events
7
Recalls
19
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2011-09-26 | Inova Diagnostics Incorporated | The NOVA Lite ANA KSL kit label has the wrong fill volume for the IFA System Negative Control (P/N 508186) with 1mL. The component in the kit is correctly labeled and filled with |
| 2010-06-30 | Bio-Rad Laboratories | KALLESTAD Mouse Stomach/Kidney (MSK) test kits contained Crithidia slides instead of the MSK slides. |
| 2008-12-04 | Immuno Concepts Inc | Samples can occasionally run out of the wells and cross contaminate adjacent wells. |
| 2008-07-29 | Bio-Rad Laboratories | The Homogeneous Positive control was released with a titer of 1:256 rather than the titer value of 1:128 reported on the QC Report Label included with each test kit. |
| 2004-09-24 | Diasorin Inc. | A problem with software for the PolyTiter Immunofluorescent Titration System in that no flags or warnings appear when PolyTiter Calibrator Values are re-entered or changed (includi |
| 2004-06-30 | Diasorin Inc. | The program for a specific immunofluorescent titration system (Polymedco PolyTiter immunofluorescent Titration System) was found faulty in that the calibrator 2 value was incorrect |
| 2003-07-21 | Perkinelmer Life Sciences, Inc. | Product's outer carton label was labeled with an extended expiration date |
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