Recall Z-2389-2012— Instrumentation Laboratory Co.
Class II · Terminated
Class II FDA medical device recall by Instrumentation Laboratory Co., initiated 2012-08-03, terminated 2015-10-02. It names one FDA 510(k) clearance: K091980. Product: Instrumentation Laboratory ACL TOP CTS PN 0000280020 ACL TOP is a 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: Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low.
- Recalling firm
- Instrumentation Laboratory Co.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-08-03
- Terminated
- 2015-10-02
- 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
Instrumentation Laboratory ACL TOP CTS PN 0000280020 ACL TOP is a 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
Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low
Data sourced from openFDA. This site is unofficial and independent of the FDA.