• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Enforcement Report - Week of September 25, 2013

  • Print
  • Share
  • E-mail
-

Event Detail

Event ID 65893
Product Type Devices
Status Ongoing
Recalling Firm Instrumentation Laboratory Co.
City Bedford
State MA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-07-19
Initial Firm Notification of
Consignee or Public
Letter
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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
ACL TOP 300 and ACL TOP 300 CTS (Japan); PN 0000280060 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. Start SN and Date: 12060256, Jun 2012; End SN and Date: 13070837, July 2013 and Start SN and Date: 11120131J, Dec 2011; End SN and Date: 13060320J, Jun2013 Class II Potential carryover issue that can can cause shortened APTT clotting times on the instrument. 662 Z-2249-2013
ACL TOP 700 CTS; PN 0000280050 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. Start SN and Date: 09120101, Dec 2009; End SN and Date: 13070304, July 2013 Class II Potential carryover issue that can can cause shortened APTT clotting times on the instrument. 185 Z-2248-2013
ACL TOP 700 LAS; PN 0000280030 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. Start SN and Date: 08120100, Dec 2008; End SN and Date: 13070172, July 2013 Class II Potential carryover issue that can can cause shortened APTT clotting times on the instrument. 56 Z-2247-2013
ACL TOP CTS; PN 0000280020 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. Start SN and Date: 06020101, Feb 2006; End SN and Date: 10080662, Aug 2010 Class II Potential carryover issue that can can cause shortened APTT clotting times on the instrument. 486 Z-2246-2013
ACL TOP 700; PN 0000280010 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. Start SN and Date: 09080100, Aug 2009 End SN and Date: 13070559, July 2013 Class II Potential carryover issue that can can cause shortened APTT clotting times on the instrument. 311 Z-2245-2013
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. Nov 2003 - Nov 2011, Serial Numbers 02110101 through 11111174 Class II Potential carryover issue that can can cause shortened APTT clotting times on the instrument. 929 Z-2244-2013
ACL TOP 500 CTS; PN 0000280040 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. Start SN and Date: 08010100 Jan 2008 - 13072599 July 2013 Class II Potential carryover issue that can can cause shortened APTT clotting times on the instrument. 2170 Z-2250-2013
-
-