FDA (Devices) recall action 68578
The FDA (Devices) publishes a recall like this one as 7 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 7 pages.
Potential for sample misidentification.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Instrumentation Laboratory Co. is recalling 1,074 ACL TOP (Base) automated coagulation laboratory instruments due to a potential for sample misidentification.
Instrumentation Laboratory Co. is recalling ACL TOP 300 CTS automated coagulation laboratory instruments due to a potential for sample misidentification.
Instrumentation Laboratory is recalling 572 ACL TOP CTS automated coagulation laboratory instruments due to a potential for sample misidentification.
Instrumentation Laboratory is recalling ACL TOP 500 CTS automated coagulation laboratory instruments due to a potential for sample misidentification.
Instrumentation Laboratory is recalling 633 ACL TOP 700 automated coagulation laboratory instruments due to a potential for sample misidentification.
Instrumentation Laboratory is recalling 99 ACL TOP 700 LAS automated coagulation laboratory instruments due to a potential for sample misidentification.
Instrumentation Laboratory is recalling 266 ACL TOP 700 CTS automated coagulation laboratory instruments due to a potential for sample misidentification.