The National Agency for Food and Drug Administration and Control (NAFDAC) has cautioned importers, distributors, healthcare professionals against the importation, distribution, and sale of COVID-19 test kits from Peru.
The Director-General of the agency, Prof. Mojisola Adeyeye, gave the caution in a statement in Abuja on Tuesday.
Adeyeye said that the product was considered to be defective by the pharmacovigilance analysis of the agency.
The director-general stressed that the test kits did not meet the required IgG specificity and IgM sensitivity standards.
She said that the Peruvian Directorate of Medicines, Supplies, and Drugs (DIGIMED), had ordered the recall of the defective COVID-19 Polymerase Chain Reaction (PCR) test kit.
According to her, the defective test kit is also said to have produced false positive and negative test results which could sabotage ongoing COVID-19 surveillance efforts.
“The Product name is Coronavirus Disease 2019 Antibody (IgM/IgG) combined test kit, Product Manufacturer is Chinese Medical System Biotechnology Co. Ltd with Lot Number 20200424.
“Polymerase chain reaction (PCR) test is a type of coronavirus test you do at home and send back to be processed in a laboratory.
“Members of the public in possession of the implicated product are implored to discontinue the sale or use and submit stock to the nearest NAFDAC office,” she said.
She also said that healthcare professionals and consumers are encouraged to report adverse events or side effects related to the use of this COVID-19 test tit to the nearest NAFDAC office.
Adeyeye encouraged the public to also report through NAFDAC PRASCOR (20543 TOLL FREE from all networks), or via [email protected] as well as the NAFDAC ADR e-Reporting platform available at www.nafdac.gov.ng