The National Agency for Food and Drug Administration and Control (NAFDAC) has issued a public notification to healthcare providers regarding Abbott’s m-PIMA HIV-1/2 VL test kits that failed to meet performance claims for HIV-1 groups O and HIV-1 group M and N throughout their claimed shelf life.
NAFDAC, in a statement, said that the discovery was made through Abbott’s internal stability monitoring programme, noting that performance for HIV-2 is not affected.
Abbott is investigating the root cause of this event and will take the necessary corrective actions to prevent future recurrences. A rigorous statistical analysis was used to identify the impacted lots, NAFDAC reported.
“m-PIMA HIV-1/2 VL cartridge is a point-of-care (POC) nucleic acid test (NAT) which directly quantifies HIV type 1 groups M/N and O, and HIV type 2 RNA in human plasma samples and differentiates HIV-1 and HIV-2 using Polymerase Chain Reaction (PCR) technology,” NAFDAC said.
The agency noted that there is a potential for patient results for viral load levels to be falsely low for HIV-1 group O and HIV-1 group M and N patients, which could lead to delayed follow-up of the patient, the patient not receiving appropriate treatment adjustment, the infection progressing, and patient health deteriorating.
Affected product details, according to NAFDAC, is:
Product Name: m-PIMA HIV-1/2 VL
Product Manufacturer: Abbott Rapid Diagnostics Jena GmbH
FSCA-Identifier: FCA-00000264
Single Registration Number (SRN): DE-MF-000025986
Impacted Reference Numbers (Catalogue Numbers): 270150050, 27015W50
Impacted Lot Numbers: 08634, 08638, 08653, 08675, 08676, 08681, 08685, 08705, 08766, 08767, 08778, 08799, 08901, 08925, 08931
Basic-UDI-DI (BUDI): 4051892HIV0002JH
NAFDAC, however, urged healthcare professionals and consumers to report any suspicion of adverse reactions, substandard or falsified medicines, diagnostic devices, and other regulated products to its nearest office.
