The National Agency for Food and Drugs Administration and Control (NAFDAC) is notifying Healthcare providers that Abbott has identified that some lots of m-PIMA HIV-1/2 VL do not meet performance claims for HIV-1 group O and HIV-1 group M and N throughout the claimed shelf life. This was discovered through an internal stability monitoring program. Please note that performance for HIV-2 is not affected.
According to Abbott, it is investigating the root cause of this event and will take the necessary corrective actions to prevent future recurrence. A rigorous statistical analysis was used to identify the impacted lots.
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.
Possible Risk
There is a potential for patient results for viral load level 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, patient not receiving appropriate treatment adjustment, the infection may progress, and patient health may deteriorate.
Product details
The details of the affected product are as follows:
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 number (catalogue number): 270150050, 27015W50
Impacted Lot Number: 08634, 08638, 08653, 08675, 08676, 08681, 08685, 08705,
08766, 08767, 08778, 08799, 08901, 08925, 08931
Basic-UDI-DI (BUDI): 4051892HIV0002JH
Product Image
Healthcare providers and Patients’ actions.
Healthcare providers and patients should inspect current inventory on-hand to determine if they have the impacted lots. Immediately discontinue use of any remaining inventory and quarantine them.
Healthcare providers should review previously reported patient results using the impacted lots and notify patients for retesting, if deemed appropriate.
Healthcare professionals and consumers are advised to report any suspicion of adverse reaction, substandard and falsified medicines, diagnostic devices and other regulated products to the nearest NAFDAC office on 0800-162-3322 or via email: sf.alert@nafdac.gov.ng
Similarly, Healthcare professionals and patients are also encouraged to report adverse events or side effects related to the use of NAFDAC regulated products to the nearest NAFDAC office, or through the use of the E-reporting platforms available on the NAFDAC website www.nafdac.gov.ng or via the Med- safety application available for download on android and IOS stores or via e-mail on pharmacovigilance@nafdac.gov.ng
NAFDAC……..Customer-focused, Agency-minded!!!
Signed Management
