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ANA Screen ELISA (IgG)
EUROIMMUN Medizinische Labordiagnostika AG · Model EA 1590-9601-8 G · UDI-DI 04049016026976
1
510(k) clearances
0
Adverse events
2
Recalls
26
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2008-08-27 | Calbiotech Inc | The recall was initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA kits. The firm reported although there is no potential health hazard related to |
| 2008-08-19 | Zeus Scientific Inc | The Calibrator Value is printed incorrectly on the Sm ELISA Test System, lot # 08041819. The Calibrator Value (CV) printed on the label is 102; the correct CV should read 266. |
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