,
The National Agency for Food and Drug Administration and Control has been informed that the Peruvian Directorate of Medicines, Supplies and Drugs (DIGIMED), on 13th April, 2021 ordered the recall of a defective COVID-19 Polymerase Chain Reaction (PCR) test kit called Coronavirus Disease 2019 Antibody (IgM/IgG) combined test kit.
It was also stated by DIGIMED, that the pharmacovigilance analysis revealed that the test kit did not meet required IgG specificity and IgM sensitivity standards. The defective test kit is also said to have produced false positive and negative test results which could sabotage ongoing COVID-19 surveillance efforts.
Polymerase chain reaction (PCR) test is a type of coronavirus test you do at home and send back to be processed in a lab.
The details of the product are as shown below;
| Product Name | Coronavirus Disease 2019 Antibody (IgM/IgG) combined test kit |
| Product Manufacturer | Chinese Medical System Biotechnology Co. Ltd |
| Lot Number | 20200424 |
NAFDAC implores importers, distributors, healthcare professionals and patients to exercise caution and vigilance to avoid the importation, distribution, sale and use of the above mentioned defective product.
Members of the public in possession of the implicated product are implored to discontinue sale or use and submit stock to the nearest NAFDAC office.
Healthcare professionals and consumers are encouraged to report adverse events or side effects related to the use of this COVID-19 Test Kit to the nearest NAFDAC office, NAFDAC PRASCOR (20543 TOLL FREE from all networks), via pharmacovigilance@nafdac.gov.ng or via the NAFDAC ADR e-Reporting platform available at www.nafdac.gov.ng
NAFDAC……..Customer-focused, Agency-minded!!!
Signed Management
