Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2409-2018 — 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

U.S. FDA — Device Enforcement · United States · 2018-03-30 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2409-2018
Date of alert: 2018-03-30
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Immuno-Mycologics, Inc
Product category: device
Product type: Devices

Reported risk: Potential for LFA strips to improperly wick which may cause false negative cryptococcosis test results

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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