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Autostat II Anti-B2-Glycoprotein I IgM
HYCOR BIOMEDICAL LLC · Model FGA23 · UDI-DI 00816879020236
10
510(k) clearances
0
Adverse events
1
Recalls
18
Facilities
Description
96 well ELISA for the detection of Anti-B2-Glycoprotein I IgM antibodies in human serum
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2004-10-26 | Diasorin Inc. | Data reduction Program written for specific sutomated microtiter plate insturment (Bio-Tek ELx800 reader) is faulty in that the positive result limit is to be greater than 15 U/ml, |
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