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Pointe Scientific, Inc. CMV IgG

HORIBA INSTRUMENTS INCORPORATED · Model T8005-96 · UDI-DI 00811727015198

LFZ Prescription

510(k) clearances

309

Adverse events

Recalls

Facilities

Description

Pointe Scientific, Inc. CMV IgG Reagent is for the detection of human IgG antibodies to cytomegalovirus virus in human serum by enzyme immunoassay, as an aid in the determination of acute or reactivated infection with CMV. When used as a qualitative test, CMV IgG EIA aids in the assessment of the patient's immunological response to CMV. These reagents have not received FDA clearance for use in testing blood or plasma donors. 96 tests

Recalls

Date	Firm	Reason
2025-11-03	GET TESTED INTERNATIONAL AB	Distribution without premarket approval/clearance.
2022-10-19	Bio-Rad Laboratories, Inc.	Due to an unusual increase in the positivity rate with human IgM antibodies to cytomegalovirus (CMV) Enzyme Immunoassay (EIA).
2017-01-11	BioMerieux SA	During development of the VIDAS 3 software version 1.2, some anomalies have been identified and observed to be already present in the current software version VIDAS 3 version 1.1.4
2015-03-26	Diamedix Corporation	Product contained an incorrect substrate.
2009-01-19	Abbott Laboratories	Defective caps: Customers have observed reagent bottles not opening appropriately, which could lead to a probe crash on the instrument.
2007-04-23	Abbott Laboratories	Failure of the AxSYM instrument to open (actuate) some reagent packs from certain lots. The defects can result in probe crashes if not detected prior to placement of the reagent k
2004-06-09	bioMerieux	The product may give false positive results.
2003-06-18	Meridian Bioscience Inc	The Low Positive Standard kit component is losing potency that may result in false positive test results.
2003-06-12	Zeus Scientific Inc	The Calibrator included within the kit may be losing reactivity.

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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.