FDA is not recommending routine testing of recipients of blood products screened using Abbott s diagnostic kits. Moreover, the blood supply is protected by several layers of overlapping measures that are designed to minimize risk, even in the very unlikely event that any one protective measure should fail. At the present time, FDA has no information to suggest that donor blood tested using kits manufactured by companies other than Abbott is safer than donor blood tested using Abbott s in vitro diagnostic test kits. FDA s action to lot release all Abbott s viral marker test kits used to screen donor blood was precautionary. At the present time, FDA has no information to suggest that using Abbott test kits will compromise the safety of the blood supply.
Alternative products are available on the U.S. market.
Listings of products regulated by CBER are available on CBER's web site. For current information on alternative manufacturers of devices regulated by CDRH, FDA recommends the use of HCFA recognized proficiency testing survey programs to obtain information on comparable marketed devices. All MDR reports are submitted on a Mandatory MedWatch reporting form. All of Abbott's in vitro diagnostic devices that have been deemed medically necessary will continue to be available. This address also contains a detailed list of the devices which will no longer be available after December 6, 1999.