Recall Z-2244-2013— Instrumentation Laboratory Co.
Class II · Terminated
Class II FDA medical device recall by Instrumentation Laboratory Co., initiated 2013-07-19, terminated 2014-10-27. It names one FDA 510(k) clearance: K091980. Product: ACL TOP (Base); PN 0000280000 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.. Reason: Potential carryover issue that can can cause shortened APTT clotting times on the instrument..
- Recalling firm
- Instrumentation Laboratory Co.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-07-19
- Terminated
- 2014-10-27
- Firm location
- Bedford, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-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 (Base); PN 0000280000 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.
Reason for recall
Potential carryover issue that can can cause shortened APTT clotting times on the instrument.
Data sourced from openFDA. This site is unofficial and independent of the FDA.