openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 1
The ImmunoCard Mycoplasma EIA detects the presence of IgM to M. pneumoniae in serum - Product Usage: intended to aid in the diagnosis of recent Mycoplasma pneumoniae infection.
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 the cause of patient symptoms. The appropriate treatment may not be administered, and symptoms may progress. Additional evaluations will be completed and documented within the associated Health Hazard Evaluation.
These labels are deterministic app interpretations, not FDA categories.
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 the cause of patient symptoms. The appropriate treatment may not be administered, and symptoms may progress. Additional evaluations will be completed and documented within the associated Health Hazard Evaluation.
Code information
Catalog Number: 709030, Lot Number: 709030M114, Device Identifier: 00840733101762.
Distribution pattern
US Nationwide distribution in the states of OH, SC.
