Terminated

ACL TOP (Base); PN 0000280000 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-2244-2013 · Posted 2013-09-18

Recalling FirmInstrumentation Laboratory Co.

Recall StatusTerminated

Product CodeGKP

Date Initiated2013-07-19

Date Terminated2014-10-27

Product Quantity929

Reason for Recall

Potential carryover issue that can can cause shortened APTT clotting times on the instrument.

Firm Action

Instrumentation Laboratory sent an Important Product Correction letter on July 19, 2013, to all affected customers. On July 23, 2013, the same communication was circulated by the IL International Group in Milan, Italy to the affected international distributors and dealers. The interim field notification was followed by the release of corrective Software V5.1.0 and Parameters P-16.3.00 (Phase II) on September 30,2013. Consignees were advised of a potential carryover issue and a workaround was provided. Consignees were asked to fax the Mandatory Response Tracking Form to 781-861-4207 or email to ra-usa.ilww.com For technical questions customers were instructed to contact the IL Technical Support Center at 1-800-678-0710, option 2. For product availability questions, customers were instructed to contact their IL Customer Service Representative at 1-800-955-9525, Option #2. For questions regarding this recall call 781-861-4467.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. Internationally to Canada, Argentina, Australia, Austria, Belarus, Belgium, Brazil, Brunei, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Dubai, Finland, France, Germany, Great Britian, Greece, Guatemala, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Korea, Kuwait, Luthuania, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Uruguay, Venezuela, and Viet Nam.

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.