FDA Device Recall Z-2065-2014: Instrumentation Laboratory Co.

Recall Res Number

Z-2065-2014

Recalling Firm / Manufacturer

Instrumentation Laboratory Co.

FEI Number

1217183

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2014-06-03

Date Posted

2014-07-16

Date Terminated

2017-09-21

Product Code

GKP

Event Number

68578

Product Quantity

266

Product Description ACL TOP 700 CTS, automated coagulation laboratory instrument.

Reason for Recall Potential for sample misidentification.

Action Details 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.

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.

Code Information / Serial Numbers Start SN and Date: 09120101 Dec 2009 End SN and Date 14050368 May 2014

Fisher Diagnostics Registration: 1181121 View Registration
INSTRUMENTATION LABORATORY CO. Registration: 1217183 View Registration
HELENA LABORATORIES, CORP. Registration: 1644474 View Registration
DIAGNOSTICA STAGO, INC. Registration: 2245451 View Registration
Siemens Healthcare Diagnostics Inc. Registration: 2432235 View Registration
SYSMEX CORPORATION KAKOGAWA FACTORY Registration: 3002759288 View Registration
Diamond Diagnostics Inc. Registration: 3006198300 View Registration
Sysmex America, Inc. Registration: 3009711478 View Registration
Sysmex RA Co., LTD, Main Office Registration: 3010188766 View Registration
BEMOTEC GMBH Registration: 3010362364 View Registration
SYSMEX CORPORATION Registration: 3010421384 View Registration
SYSMEX CORPORATION i-SQUARE Registration: 3010960914 View Registration
Sysmex America, Inc. - Vernon Hills Registration: 3020704087 View Registration
INSTRUMENTATION LABORATORY CO. - Devens Registration: 3037000637 View Registration
Diagnostica Stago - Gennevilliers Registration: 8043723 View Registration
Siemens Healthcare Diagnostics Products GmbH Registration: 9610806 View Registration
SYSMEX CORPORATION TECHNO PARK Registration: 9613959 View Registration

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Medical Device Recall: Z-2065-2014

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