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

BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742

Due to increase in false negative results

Biofire Spotfire Respiratory/Sore Throat Panel

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

BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)

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

DASH SARS-CoV-2 & Flu A/B Test

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

Brand Name: QIAstat-Dx

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

Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400

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

The BIOFIRE Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed nucleic acid test intended for use with the BIOFIRE FILMARRAY 2.0 or BIOFIRE FILMARRAY Torc

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.

BioFire Respiratory Panel 2.1 (RP2.1), REF: 423742, For FILMARRAY systems, IVD, Rx Only

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

In Vitro Diagnostic (IVD) Panel

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.