Instrumentation Laboratory ACL TOP (Base) PN 0000280000 ACL TOP is a bench top, fully automat...

FDA Device Recall #Z-2387-2012 — Class II — August 3, 2012

Recall Summary

Recall Number Z-2387-2012
Classification Class II — Moderate risk
Date Initiated August 3, 2012
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Instrumentation Laboratory Co.
Location Bedford, MA
Product Type Devices
Quantity 1074 units

Product Description

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

Reason for Recall

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

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.

Lot / Code Information

Serial Number range:03110101 through 11111174 Distributed from: Nov 2003 to Nov 2011

Other Recalls from Instrumentation Laboratory Co.

Recall # Classification Product Date
Z-2487-2019 Class II ROTEM ex-tem Rest of the world part No: 503-05... Jul 23, 2019
Z-2486-2019 Class II ROTEM ex-tem Canada Part No: 503-05-CA Jul 23, 2019
Z-2485-2019 Class II ROTEM ex-tem; US Part No: 503-05-US Jul 23, 2019
Z-0077-2019 Class II Hemosll ReadiPlasTin (10 mL Size), Part Number ... Aug 1, 2018
Z-0895-2018 Class II Hemosll ReadiPlasTin (20 ml Size), Part Number ... Aug 2, 2017

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.