May 2015:Temporary cessation of procurement of non-HIV rapid and ELISA diagnostics tests not FDA approved or WHO pre-qualified
Please note that recent quality problems with rapid tests for HCV and syphilis has prompted USAID to review its quality assurance policy for the procurement of non-HIV rapid and other diagnostics. For this reason, USAID has formally instructed SCMS to temporarily cease the procurement of all non-HIV rapid and ELISA diagnostics tests that are not either FDA approved or WHO pre-qualified and cancel all orders placed for the subject products immediately. Until further notice SCMS will not be accepting orders for these tests.
Over the next few weeks, SCMS will work with USAID to determine the way forward for these tests.
February 2015 Product Recall: Benzylpenicillin Procaine and Benzylpenicillin Benzathine
During an inspection conducted on November 27, 2014, the French National Agency for Medicines and Health Products Safety found that the Active Pharmaceutical Ingredient (API) manufacturer North China Pharmaceutical Group Semisyntech Co., Ltd., is non-compliant in meeting GMP requirements in the production of sterile:
These materials were used by Panpharma to manufacture products which were supplied to Ethiopia and Liberia are now being recalled. If any organizations have recently received this product, SCMS recommends contacting the supplier as soon as possible. Learn more
February 2012 Product Recall: ImmunoComb® II HIV 1&2 Bispot
The following lots have been recalled and should be discarded as advised by the manufacturer: 110612, 110612M, 1106121M, 110620. Learn More
January 4, 2011: SD Bioline HIV kits
Recent events in the HIV test kit market have reminded us of the significant risks all testing programs face. The test kit market has been dominated by three HIV diagnostic tests; including:
Determine: about 75 percent for Partnership for Supply Chain Management (PFSCM) shipments the last three years
Uni-Gold: about 11 percent
Bioline: about 9 percent
The World Health Organization (WHO) and the United States Agency for International Development (USAID) have removed SD Bioline HIV kits from their waiver lists until further notice due to quality assurance (QA) problems. Read more