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U.S. Department of Health and Human Services

Class 2 Device Recall PREMIER Cryptococcal Antigen enzyme immunoassay (EIA)

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 Class 2 Device Recall PREMIER Cryptococcal Antigen enzyme immunoassay (EIA)see related information
Date Initiated by FirmDecember 17, 2018
Create DateJanuary 14, 2019
Recall Status1 Terminated 3 on April 30, 2020
Recall NumberZ-0732-2019
Recall Event ID 81787
510(K)NumberK904393 
Product Classification Antigen, elisa, cryptococcus - Product Code MDU
ProductPREMIER Cryptococcal Antigen, Catalog Number 602096 Product Usage: The PREMIER Cryptococcal Antigen enzyme immunoassay (EIA) is a screening or a semi-quantitative test system for the detection of capsular polysaccharide antigens of Cryptococcus neoformans in serum and cerebrosoinal fluid (CSF).
Code Information Lot Numbers: 602096K089, 602096K090, 602096K091
Recalling Firm/
Manufacturer		 Meridian Bioscience Inc
3471 River Hills Dr
Cincinnati OH 45244-3023
For Additional Information ContactChris Ross
513-271-3700
Manufacturer Reason
for Recall		An enzyme reagent included in the kit is not maintaining stability through claimed product expiration, resulting in the potential for false negative results when tested with patient specimens and the positive control.
FDA Determined
Cause 2		Unknown/Undetermined by firm
ActionUrgent: Voluntary Medical Device Recall notification letters dated 12/17/18 were distributed to customers. The letter identified the affected product, problem and actions to be taken. The letters instructed customers to review inventory for affected lots, forward the letter to any customers, contact the firm replacement product, complete the response form. For questions contact Meridian's Technical Service Department by telephone at 800-343-3858 or 513-271-3700 or by facsimile 513-272-5432.
Quantity in Commerce184
DistributionWorldwide Distribution - US Nationwide in the states of: AK, CA, CO, DE, IL, KS, KY, LA, MD, MO, NC, ND, NJ, NY, SC, TX, and VA. The products were distributed to the following foreign countries: India and Italy.
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 = MDU
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