FDA Medical Device Recalls (openFDA)
Meridian Bioscience Inc: 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.
- Recall number
- Z-1299-2021
- Recalling firm
- Meridian Bioscience Inc
- Product
- 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.
- Status
- Terminated
- Initiated
- 2021-02-08
- Posted
- not on file
- Terminated
- 2021-10-26
- Reason
- 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.
- Root cause
- Storage
- Action
- On 02/19/2021, Meridian issued an Urgent Medical Device Correction notice to customers via letter for ImmunoCard Mycoplasma kits from a specified lot. Upon receipt at the Cardinal Health Charlotte distribution center, the kits were identified to have a transit time of 115 hours with a maximum temperature of 55 F (approximately 12 C). This is beyond our transit time requirement of 72 hours and storage at 2-8 C. Cardinal placed the kits into a quarantine location, however 8 kits were inadvertently shipped to your facility.
- Quantity
- 8 kits
- Distribution
- US Nationwide distribution in the states of OH, SC.
- Lot, serial or model codes
- Catalog Number: 709030, Lot Number: 709030M114, Device Identifier: 00840733101762.
- 510(k) numbers
- ["K934550"]
- PMA numbers
- not on file
- Product code
- LJZ
- Firm FEI
- 1524213
- Firm city
- Cincinnati
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28