ImmunoWELL™ MYCOPLASMA PNEUMONIAE ANTIBODY (IgG) TEST
GenBio · Model 800-3120 · UDI-DI 00613745031200
LJZ
Prescription
10
510(k) clearances
0
Adverse events
4
Recalls
14
Facilities
Description
ImmunoWELL Mycoplasma Pneumoniae Antibody (IgG) Test is a semi–quantitative or qualitative determination of IgG antibodies in human serum to Mycoplasma pneumoniae for the determination of immunological experience. The test may be used to evaluate paired sera for the presence of seroconversion and a significant increase in specific IgG and in the diagnosis of Mycoplasma pneumoniae infection in the adult population.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-02-08 | Meridian Bioscience Inc | Use 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 |
| 2008-08-27 | Calbiotech Inc | The 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, |
| 2008-08-27 | Calbiotech Inc | The 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, |
| 2008-08-27 | Calbiotech Inc | The 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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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.