The National Agency for Food and Drug Administration and Control has cautioned importers, distributors, healthcare professionals against the importation, distribution and sale of COVID-19 test kits from Peru.
This was disclosed in a statement by the Director-General of the agency, Prof. Mojisola Adeyeye.
According to Adeyeye, 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 explained that the Peruvian Directorate of Medicines, Supplies and Drugs had ordered the recall of the defective COVID-19 Polymerase Chain Reaction test kit.
According to Adeyeye, the defective test kit is also said to have produced false positive and negative test results, which could sabotage ongoing COVID-19 surveillance efforts.
She said: “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.”
Adeyeye also said 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] nafdac.gov.ng as well as the NAFDAC ADR e-Reporting platform available.