Manufacturer
11 recalls in our database name Focus Diagnostics Inc as the manufacturing or recalling firm.
Of the 11 recalls from Focus Diagnostics Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.
The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.
Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.
Focus Diagnostics is recalling Legionella IFA Substrate Slides because the device was found not to be 510(k) exempt.
Focus Diagnostics is recalling Legionella IFA devices because the company discovered the product is not 510(k) exempt. The recall affects 196 units distributed to three testing laboratories.
Focus Diagnostics is recalling Simplexa Direct Amplification Discs because they may cause false test results or error codes.
Focus Diagnostics is recalling Simplexa Group A Strep Direct Amplification Discs because they may cause false test results or error codes.
Focus Diagnostics is recalling Simplexa HSV 1&2 Direct Amplification Discs because they may cause false negative or positive results and error codes.
Focus Diagnostics is recalling 38 Anaplasma phagocytophilum IFA IgM Test Kits due to a potential increase in invalid results.
Focus Diagnostics is recalling 300 units of the Stratify JCV DxSelect assay (Lot 27333) because a non-conforming batch may cause false positive results.
Focus Diagnostics is correcting labeling for 614 Simplexa Flu A/B & RSV Direct kits due to sporadic false signals that may increase false results.
Focus Diagnostics is recalling Simplexa Flu A/B & RSV Direct Assay Kits due to the potential for false positive test results.
Focus Diagnostics is recalling 1,052 Simplexa Flu A/B & RSV Direct assay kits due to sporadic false positive RSV signals that may lead to incorrect diagnostic results.
Focus Diagnostics is recalling specific lots of West Nile Virus IgG test kits due to a higher false positive rate.