EasyScreen™ Gastrointestinal Parasite PCR Positive Control
GENETIC SIGNATURES LIMITED · Model 1 · UDI-DI 09351179004070
Description
The EasyScreen™ Gastrointestinal Parasite PCR Positive Control (PC-PROT-001) is a control material for nucleic acid testing of patient clinical samples. It is designed to provide a positive PCR signal for each of the protozoan targets in the EasyScreen™ Gastrointestinal Parasite Detection Kit (EP005). The Positive Control does not require processing and is designed to be added directly to the PCR mastermix when a positive signal in all detection channels is required for quality control purposes. This Positive Control demonstrates that all PCR targets are being detected as expected, and does not provide any results from clinical specimens. This Positive Control is for Investigational in vitro Diagnostic (IVD) Use Only in hospital and pathology laboratories or similar, by trained personnel.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2024-05-16 | BioFire Diagnostics, LLC | Due to increase of false positive Vibrio/Vibrio Cholerae results when using a certain transport medium. |
| 2024-01-26 | BioFire Diagnostics, LLC | Due to potential signals of increased false positive Norovirus results when using the gastrointestinal (GI) panel. |
| 2023-11-27 | BioFire Diagnostics, LLC | A manufacturing event may contribute to elevated rates of false negative results while using gastrointestinal panel and respiratory panel, which could lead to inappropriate antibio |
| 2023-06-05 | Luminex Corporation | It is possible that in rare instances the VERIGENE CDF Nucleic Acid Test Kit (Part No. 20-005-022) and the VERIGENE Enteric Pathogens Nucleic Acid Test Kit (Part No. 20-005-023) co |
| 2023-04-25 | BioFire Diagnostics, LLC | The firm has identified an increased risk of obtaining false positive Cryptosporidium results from customers using the BIOFIRE FILMARRAY Gastrointestinal (GI) Panel |
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