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NOVA Lite® ANA KSL Kit
INOVA DIAGNOSTICS, INC. · Model 708390 · UDI-DI 08426950506324
DHN
Prescription
1
510(k) clearances
1
Adverse events
7
Recalls
19
Facilities
Description
1. 10x 4-well ANA KSL Substrate Slides 2. 1x 7mL FITC Anti Human IgG Conjugate 3. 1x 0.5 mL ANA Homogeneous Pattern 4. 1x 0.5mL IFA System Negative Control 5. 1x 25mL PBS Concentrate (40x) 6. 1x 7mL Mounting Medium 7. 1x 10 Coverslips
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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