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Terminated

ACL TOP 500 CTS, automated coagulation laboratory instrument.

FDA Recall Z-2064-2014 · Posted 2014-07-16

Recalling FirmInstrumentation Laboratory Co.
Recall StatusTerminated
Product CodeGKP
Date Initiated2014-06-03
Date Terminated2017-09-21
Product Quantity2802

Reason for Recall

Potential for sample misidentification.

Firm Action

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: [email protected]. For technical questions, consignees should contact the IL Technical Support Center at 1-800-678-0710.

Root Cause

Device Design

Distribution Pattern

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.

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.

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