Recalls for Multi-target Respiratory Specimen Nucleic Acid Test Including Sars-cov-2 And Other Microbial Agents

Due to increase in false negative results

Respiratory/sore throat panel test may result in false negative results and control failures.

Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures.

Due to manufacturing error, assay test may result in missed diagnosis or delay of treatment. (Potential false negative result)

Identified faulty cartridges. If such a faulty cartridge is used for sample testing, false test results could occur.

SARS-CoV-2/Flu A/B/RSV Assay Kit may erroneously produce SARS-CoV-2 false positive results.

A manufacturing event may contribute to elevated rates of false negative results while using gastrointestinal panel and respiratory panel, which could lead to inappropriate antibiotic treatment, no treatment, delay of treatment, and may provide false assurance to someone with a true infection, delayed identification of an outbreak, and may result in additional transmission.

Due to manufacturing issue, panels may result in false negative results.

Due to temperature excursions with products (products being stored outside of the required temperature specifications) that may cause a reduction in performance. The temperature excursion was as a result of shipping delays.