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ASI SLE Slide Test

ARLINGTON SCIENTIFIC, INC. · Model NC-350100E · UDI-DI 00816057020249

DHC
1
510(k) clearances
0
Adverse events
1
Recalls
5
Facilities

Description

Detection of Anti-DNP, associated with Systemic Lupus Erythematosus, Export

Recalls

DateFirmReason
2009-07-14Bio-Rad Laboratories IncThe firm received customer complaints of microbial contamination in Positive Controls in its Anti-Cardiolipin IgM Test Kit Lot CL-863.

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Data 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.