IMMUNOFLOW™ Mycoplasma pneumoniae IgM Test
GenBio · Model 800-7005 · UDI-DI 00613745000060
LJZ
Prescription
10
510(k) clearances
0
Adverse events
4
Recalls
14
Facilities
Description
ImmunoFLOW Mycoplasma pneumoniae IgM Test detects human IgM to the complement-fixing antigen and is intended as an aid in the diagnosis of infection.
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.