Recall Z-2061-2014— Instrumentation Laboratory Co.

Name: FDA recall Z-2061-2014
Creator: U.S. Food and Drug Administration
Published: 2014-06-03

Class II · Terminated

Class II FDA medical device recall by Instrumentation Laboratory Co., initiated 2014-06-03, terminated 2017-09-21. It names one FDA 510(k) clearance: K091980. Product: ACL TOP 700, automated coagulation laboratory instrument.. Reason: Potential for sample misidentification..

Recalling firm: Instrumentation Laboratory Co.
Classification: Class II
Status: Terminated
Initiated: 2014-06-03
Terminated: 2017-09-21
Firm location: Bedford, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K091980 — ACL TOP 700 LASInstrumentation Laboratory CO·cleared 2009-09-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

ACL TOP 700, automated coagulation laboratory instrument.

Reason for recall

Potential for sample misidentification.

Data sourced from openFDA. This site is unofficial and independent of the FDA.