Z-1299-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 31, 2021
- Initiation Date
- February 8, 2021
- Termination Date
- October 26, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8 kits
Product Description
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.
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution in the states of OH, SC.
Code Information
Catalog Number: 709030, Lot Number: 709030M114, Device Identifier: 00840733101762.