Z-1299-2021Class II

The ImmunoCard Mycoplasma EIA detects the presence of IgM to M. pneumoniae in serum -

Name: Z-1299-2021 The ImmunoCard Mycoplasma EIA detects the presence of IgM to M. pneumoniae in serum -
Creator: Meridian Bioscience Inc
Published: 2021-02-08
License: https://open.fda.gov/license/

Meridian Bioscience Inc / initiated 2021-02-08 / Terminated

FDA source

Meridian Bioscience Inc began a recall of 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... on 2021-02-08. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1299-2021
Classification: Class II
Status: Terminated
Initiated: 2021-02-08
Posted: 2021-03-24
Terminated: 2021-10-26
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.
Product code: LJZ Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.
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.
FDA 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 in commerce: 8 kits
Distribution: US Nationwide distribution in the states of OH, SC.
Product codes and lots: Catalog Number: 709030, Lot Number: 709030M114, Device Identifier: 00840733101762.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1299-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1299-2021	Class II	Terminated	Voluntary: Firm initiated	2021-03-31	2021-03-24

Product code LJZ

K934550Class IImmunocard MycoplasmaMeridian Diagnostics, Inc. / cleared 1994-09-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)