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HemosIL AcuStar Anti-B2GPI Domain 1
INSTRUMENTATION LABORATORY COMPANY · Model 00009800015 · UDI-DI 08426951298778
MSV
Prescription
1
510(k) clearances
0
Adverse events
1
Recalls
18
Facilities
Description
1. HemosIL Acustar ß2GP1-Domain1 Reagent Cartridge (Cat. No. 00009800016 2. 1 Resuspension buffer (Cat. No. 00009800019) 3. 1 HemosIL Acustar ß2GP1-Domain1 Calibrator 1 (Cat. No. 00009800017): 4. 1 HemosIL Acustar ß2GP1-Domain1 Calibrator 2 (Cat. 00009800018):
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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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.