Instrumentation Laboratory Co. Recall: Instrumentation Laboratory ACL TOP 700 CTS PN 00002
Instrumentation Laboratory Co. Recall: Instrumentation Laboratory ACL TOP 700 CTS PN 00002 is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Instrumentation Laboratory Co.; Product: Instrumentation Laboratory ACL TOP 700 CTS PN 0000280050 ACL TOP is a bench top, fully automated, random a
| Recalling firm | Instrumentation Laboratory Co. |
|---|---|
| Product | Instrumentation Laboratory ACL TOP 700 CTS PN 0000280050 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 |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Worldwide distribution: USA (nationwide) and countries of: ARGENTINA, AUSTRALIA, AUSTRIA, BELARUS, BELGIUM, BRAZIL, BRUNEI DARUSSALAM, BULGARIA, CHILE, CHINA, DENMARK, FINLAND, FRANCE, GERMANY, HONG KONG, HUNGARY, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, KOREA, REPUBLIC OF LUXEMBOURG, MACAU, MALAYSIA, |
| Recall initiated | 20120803 |
| Recall number | Z-2392-2012 |
| Category | device |
| State | MA |
| Country | United States |
$29/mo
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