Immuno-Mycologics Recalls Cryptococcal Antigen Lateral Flow Assay Strips
Immuno-Mycologics is recalling 875 units of Cryptococcal Antigen Lateral Flow Assay strips due to a defect that may cause false negative test results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device defect that may cause false negative diagnostic results, representing a risk of harm where injury has not yet been reported, consistent with the 'High' severity criteria.
Plain-English summary
Immuno-Mycologics, Inc. is recalling 875 units of the Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Model # CR2003. The recall affects specific lots (L102802 and L103012) of the immunochromatographic test system used to detect cryptococcosis in serum and cerebral spinal fluid.
The recall was initiated because the lateral flow assay strips may improperly wick, which can result in false negative test results for cryptococcosis. On March 30, 2018, the manufacturer began issuing urgent medical device recall notices to customers via email.
Customers are advised to continue using the affected lots but must consider any testing performed on defective strips invalid and repeat the tests. Laboratory personnel should look for defective strips, which are identified by fast wicking and/or very weak control lines. Customers must complete the Acknowledgement and Receipt Form and submit it to the manufacturer, even if no affected stock remains. If replacement kits are needed, customers must return their affected inventory according to instructions provided by customer service.
The recalled product
- 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…
- Manufacturer
- Immuno-Mycologics, Inc
- Affected units
- 875
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot/Serial Numbers: L102802 and L103012
Distribution
Distribution scope not specified by the agency.
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