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Pointe Scientific, Inc. CMV IgM
HORIBA INSTRUMENTS INCORPORATED · Model T8006-96 · UDI-DI 00811727015204
LFZ
Prescription
1
510(k) clearances
309
Adverse events
9
Recalls
29
Facilities
Description
Pointe Scientific, Inc. CMV IgM Reagent is for the qualitative detection of human IgM antibodies to cytomegalovirus (CMV) in human serum by enzyme immunoassay, to aid in the diagnosis of CMV infection. A positive result is presumptive for the detection of anti-CMV IgM antibodies and presumptive for the diagnosis of acute or recent CMV infection. 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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Get your free API keyRead the docsData 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.