ACL TOP 500 CTS, automated coagulation laboratory instrument.
This recall has been terminated (originally issued July 16, 2014).
- Company
- Instrumentation Laboratory Co.
- Recall Initiated
- June 3, 2014
- Posted
- July 16, 2014
- Terminated
- September 21, 2017
- Recall Number
- Z-2064-2014
- Quantity
- 2802
- Firm Location
- Bedford, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Potential for sample misidentification.
Distribution
Worldwide Distribution-USA (nationwide) including the states of 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, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV, and the countries of Canada, Mexico, Argentina, Australia, Austria, Belarus, Belgium, Bolivia, Brazil, Brunei, Chile, China, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, El Salvador, Finland, France, Germany, Gibraltar, Great Britain, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Kuwait, Libya, Lithuania, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Quatar, Romania, Russia, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, UAE, Uruguay, Venezuela, Vietnam.
Lot / Code Info
Start SN and Date: 08010100 Jan 2008 End SN and Date 14052901 May 2014
Root Cause
Device Design
Action Taken
Consignees were notified via phone starting on June 3, 2014. On June 4, a USPS mailing was sent to all US/Canadian customers. On June 4, 2014, email notifications were sent to the IL Affiliates and International Distributors/Dealers (through the International Group) requesting them to translate the Field Safety Notice and provide notification to their customer base and secondary distributors. The Urgent Product Correction letter informs consignees of the issue and provides workaround instructions. Consignees are asked to complete a Mandatory Response Tracking Record and return it via Fax (781)861-4207 or email: ra-usa@ilww.com. For technical questions, consignees should contact the IL Technical Support Center at 1-800-678-0710.