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Trinity Biotech

CLARK LABORATORIES, INC. · Model 2344800 · UDI-DI 05391516743945

LJZ
1
510(k) clearances
0
Adverse events
4
Recalls
14
Facilities

Description

Captia Mycoplasma IgG

Recalls

DateFirmReason
2021-02-08Meridian Bioscience IncUse of the kits after incorrect storage could lead to a potential false-negative or invalid result. In the event of a false-negative, the incorrect assumption would be made as to t
2008-08-27Calbiotech IncThe recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA kits. Although there is no potential health hazard related to this recall,
2008-08-27Calbiotech IncThe recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA kits. Although there is no potential health hazard related to this recall,
2008-08-27Calbiotech IncThe recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA kits. Although there is no potential health hazard related to this recall,

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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.