ACL TOP (Base); PN 0000280000 Bench top, fully automated, random access analyzer designed specifically for in vitro diag

FDA device recall Z-2244-2013 · posted 2013-09-18 · Terminated

Recall details

Recalling firm

Instrumentation Laboratory Co.

Reason for recall

Potential carryover issue that can can cause shortened APTT clotting times on the instrument.

Action taken

Instrumentation Laboratory sent an Important Product Correction letter on July 19, 2013, to all affected customers. On July 23, 2013, the same communication was circulated by the IL International Group in Milan, Italy to the affected international distributors and dealers. The interim field notification was followed by the release of corrective Software V5.1.0 and Parameters P-16.3.00 (Phase II) on September 30,2013. Consignees were advised of a potential carryover issue and a workaround was provided. Consignees were asked to fax the Mandatory Response Tracking Form to 781-861-4207 or email to ra-usa.ilww.com For technical questions customers were instructed to contact the IL Technical Support Center at 1-800-678-0710, option 2. For product availability questions, customers were instructed to contact their IL Customer Service Representative at 1-800-955-9525, Option #2. For questions regarding this recall call 781-861-4467.

Root cause

Device Design

Status

Terminated

Product code

GKP

Quantity affected

929

Distribution

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, U

Date initiated

2013-07-19

Date posted

2013-09-18

Date terminated

2014-10-27

Location

Bedford, MA

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