Recall Z-0732-2019— Meridian Bioscience Inc
Class II · Terminated
Class II FDA medical device recall by Meridian Bioscience Inc, initiated 2018-12-17, terminated 2020-04-30. It names one FDA 510(k) clearance: K904393. Product: PREMIER 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).. Reason: 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..
- Recalling firm
- Meridian Bioscience Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-12-17
- Terminated
- 2020-04-30
- Firm location
- Cincinnati, OH, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
PREMIER 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).
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.