Z-1299-2021 Class II Terminated
FDA device recall Z-1299-2021 was initiated by Meridian Bioscience Inc on February 8, 2021 and is designated Class II. 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 … The recall status is terminated (terminated October 26, 2021). Affected quantity: 8 kits.
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.