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T4 AccuLite CLIA Test System - 960 Wells

MONOBIND, INC. · Model 275-300 · UDI-DI 00816870023120

CDX Prescription
10
510(k) clearances
100
Adverse events
1
Recalls
13
Facilities

Recalls

DateFirmReason
2025-06-04DRG International, Inc.An incoming complaint reported that the expiration date on the kit box label and Certificate of Analysis (CoA) exceeded the shelf life of the standards and control solutions in the

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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.