Recall Z-2409-2018— Immuno-Mycologics, Inc
Class II · Terminated
Class II FDA medical device recall by Immuno-Mycologics, Inc, initiated 2018-03-30, terminated 2020-05-21. It names one FDA 510(k) clearance: K112422. Product: Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Model # CR2003 Product Usage: The CrAg Lateral Flow Assay is an immunochromatographic test system for the qualitative or semi-quantitative detection of the capsular polysaccharide antigens of Cryptococcus species complex (Cryptococcus neoformans and Cryptococcus gattii) in serum and cerebral spinal fluid (CSF). The CrAg Lateral Flow Assay is a prescription-use laboratory assay which can aid in the diagnosis of cryptococcosis.. Reason: Potential for LFA strips to improperly wick which may cause false negative cryptococcosis test results.
- Recalling firm
- Immuno-Mycologics, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-03-30
- Terminated
- 2020-05-21
- Firm location
- Norman, OK, 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
Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Model # CR2003 Product Usage: The CrAg Lateral Flow Assay is an immunochromatographic test system for the qualitative or semi-quantitative detection of the capsular polysaccharide antigens of Cryptococcus species complex (Cryptococcus neoformans and Cryptococcus gattii) in serum and cerebral spinal fluid (CSF). The CrAg Lateral Flow Assay is a prescription-use laboratory assay which can aid in the diagnosis of cryptococcosis.
Reason for recall
Potential for LFA strips to improperly wick which may cause false negative cryptococcosis test results
Data sourced from openFDA. This site is unofficial and independent of the FDA.