Company:Instrumentation Laboratory Co.
Date of Enforcement Report 12/8/2010
Class ll:
PRODUCT
1) ACL TOP (Base) PN 000280000 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. Recall # Z-0135-2011;
2) ACL TOP 500 CTS PN 000280040 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. Recall # Z-0136-2011;
3) ACL TOP 700 LAS PN 000280030 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. Recall # Z-0137-2011;
4) ACL TOP CTS PN 000280020 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. Recall # Z-0138-2011
REASON
Software: New data check, “Multiple Threshold Check”, was added to identify and fail abnormal (bimodal) clot curves.
RECALLING FIRM/MANUFACTURER
Instrumentation Laboratory Co., Bedford, MA, by letter on August 13, 2010. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
1,066 units
DISTRIBUTION
Nationwide and Canada
