Reported Jul 18, 2018 · Terminated
Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Model # CR2003 Product Usage: The CrAg Lateral Flow Assay is an…
Immuno-Mycologics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Immuno-Mycologics, Inc · 2700 Technology Pl · Norman, OK · 73071-1127
Is this the product you have?
- Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Model #
- CR2003 Product UsageThe 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
- Lot codes and dates
- Lot/Serial NumbersL102802 and L103012
- Amount recalled
- 875 units
Why it was recalled
Potential for LFA strips to improperly wick which may cause false negative cryptococcosis test results
This product could cause temporary or reversible health problems — stop using it.
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