Biologic recalls tagged "Device defect"
Recalls of blood, tissue, vaccines and related products regulated by FDA’s biologics center, newest first. 6 recalls Each recall is dated by the day its recall page names (how recalls are dated).
1 recall that day
Diagnostic Grifols Erytra and Erytra Eflexis Automated Blood Grouping and Antibody Test Systems
An issue in how these blood grouping systems titrate antibodies can cause minor variations in titration results.
2 products
1 recall that day
Abbott Determine HIV 1/2 Ag/Ab Combo
Determine HIV 1/2 Ag/Ab Combo 25T kits may give false positive results due to a subcomponent.
3 recalls that day
ALBA Bioscience ALBAzyme Papain Solution Kit
ALBAzyme Papain Solution Kit may have reduced activity, causing incomplete removal of enzyme-sensitive antigens from red blood cells.
ALBA Bioscience Ortho Sera Papain
ORTHO Sera Papain has reduced reactivity, which may cause hemolytic transfusion reactions.
Terumo BCT Rika Plasma Donation System
The Rika Plasma Donation System has a potential safety issue with an electrical component in its control valve.
1 recall that day
Thermo Fisher Scientific TSCM17, TSCM34 and TSCM48 Laboratory Freezers
The CryoMed Controlled-Rate Freezer may have a heater that can trip a circuit breaker or shock the user.
