Corrective action / recall for all PT- / APTT-based IL Locked Test Groups on ACL Elite, ACL Elite Pro, ACL 8000, ACL 9000 and ACL 10000 Coagulation Analyzers, Instrumentation Laboratory
2012.01.27
Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 04496/10
Corrective action / recall of Instrumentation Laboratory for all PT- / APTT-based IL Locked Test Groups on ACL Elite, ACL Elite Pro, ACL 8000, ACL 9000 and ACL 10000 Coagulation Analyzers because of sporadically lowered APTT results.
An additional customer information was released by the manufacturer (see also BfArM case no. 4496/10 of 2010-12-29).