ACL TOP 500 CTS, automated coagulation laboratory instrument.

FDA device recall Z-2064-2014 · posted 2014-07-16 · Terminated

Recall details

Recalling firm

Instrumentation Laboratory Co.

Reason for recall

Potential for sample misidentification.

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.

Root cause

Device Design

Status

Terminated

Product code

GKP

Quantity affected

2802

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,

Date initiated

2014-06-03

Date posted

2014-07-16

Date terminated

2017-09-21

Location

Bedford, MA

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