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Monobind AccuLite TBG CLIA Kit - 96 Wells

MONOBIND, INC. · Model 3575-300 · UDI-DI 00816870023199

CEE
10
510(k) clearances
0
Adverse events
1
Recalls
9
Facilities

Recalls

DateFirmReason
2015-04-09Siemens Healthcare Diagnostics, Inc.IMMULITE/IMMULITE 1000 TBG catalog LKTB lot 257 is failing the adjustment slope instrument parameter of <1.80. The resulting slope of the kit is >1.80 resulting in the potential t

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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.