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U.S. Department of Health and Human Services

Class 2 Device Recall ImmunoCard Mycoplasma

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 Class 2 Device Recall ImmunoCard Mycoplasmasee related information
Date Initiated by FirmFebruary 08, 2021
Create DateMarch 24, 2021
Recall Status1 Terminated 3 on October 26, 2021
Recall NumberZ-1299-2021
Recall Event ID 87430
510(K)NumberK934550 
Product Classification Enzyme linked immunoabsorbent assay, mycoplasma spp. - Product Code LJZ
ProductThe 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.
Code Information Catalog Number: 709030, Lot Number: 709030M114, Device Identifier: 00840733101762. 
FEI Number 1524213
Recalling Firm/
Manufacturer		 Meridian Bioscience Inc
3471 River Hills Dr
Cincinnati OH 45244-3023
For Additional Information ContactChris Ross
800-343-3858
Manufacturer 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 Determined
Cause 2		Storage
ActionOn 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 Commerce8 kits
DistributionUS Nationwide distribution in the states of OH, SC.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = LJZ
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