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All product recalls associated with Chembio Diagnostic System Inc.
Total Recalls
2
Past Year
0
Class I (Serious)
0
Most Recent
Dec 2005
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
Firm received one report of a false negative with the positive control. Internal testing by the firm has shown that the kit lot may result in invalid or false negative interpretations.
Poor sealing of pouches and degradation of products. Firm received an e-mail from a distributor of an increase in complaints. In response to the complaints, the distributor conducted its own functional testing and noticed a degradation in performance of the two lots. Chembio's investigation revealed invalid results (no control lines) and some false negatives.