Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Instrumentation Laboratory ACL TOP (Base) PN 0000280000 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

FDA Recall Z-2387-2012 · Posted 2012-09-14

Recalling FirmInstrumentation Laboratory Co.
Recall StatusTerminated
Product CodeGKP
Date Initiated2012-08-03
Date Terminated2015-10-02
Product Quantity1074 units

Reason for Recall

Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low

Firm Action

The firm, Instrumentation Laboratory, sent a "Mandatory Test Parameter Upgrade" letter dated June 7, 2012 with upgrade kits P-14.8 via USPS on August 3 thru August 10 to US and Canadian customers and notified International Affiliates via e-mail on August 2, 2012. The customers were ask to complete and return the Mandatory Test Parameter Upgrade Tracking Form via fax: 781-861-4207 or email: [email protected]. If you have any questions, call 781-861-4204.

Root Cause

Software design

Distribution Pattern

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, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, PANAMA, PERU, POLAND, PORTUGAL, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SLOVAKIA (Slovak Republic), SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, PROVINCE OF CHINA, THAILAND, TURKEY, UNITED KINGDOM, URUGUAY and VIETNAM.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K091980ACL TOP 700 LASInstrumentation Laboratory CO · 2009-09-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑