Z-2250-2013Class II

ACL TOP 500 CTS; PN 0000280040 Bench top, fully automated, random access analyzer designed specifically for...

Name: Z-2250-2013 ACL TOP 500 CTS; PN 0000280040 Bench top, fully automated, random access analyzer designed specifically for...
Creator: Instrumentation Laboratory Co.
Published: 2013-07-19
License: https://open.fda.gov/license/

Instrumentation Laboratory Co. / initiated 2013-07-19 / Terminated / root cause: design

FDA source

Instrumentation Laboratory Co. began a recall of ACL TOP 500 CTS; PN 0000280040 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis... on 2013-07-19. FDA classified it as Class II and gives the reason as "Potential carryover issue that can can cause shortened APTT clotting times on the instrument". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2250-2013
Classification: Class II
Status: Terminated
Initiated: 2013-07-19
Posted: 2013-09-18
Terminated: 2014-10-27
Recalling firm: Instrumentation Laboratory Co.
Product: ACL TOP 500 CTS; PN 0000280040 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.
Product code: GKP Instrument, Coagulation, Automated
Reason for recall: Potential carryover issue that can can cause shortened APTT clotting times on the instrument.
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 2170
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, UT, VA, VT, WA, WI, and WV. Internationally to Canada, Argentina, Australia, Austria, Belarus, Belgium, Brazil, Brunei, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Dubai, Finland, France, Germany, Great Britian, Greece, Guatemala, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Korea, Kuwait, Luthuania, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Uruguay, Venezuela, and Viet Nam.
Product codes and lots: Start SN and Date: 08010100 Jan 2008 - 13072599 July 2013

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2250-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2244-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-18
Z-2245-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-18
Z-2246-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-18
Z-2247-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-18
Z-2248-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-18
Z-2249-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-18
Z-2250-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-18

Product code GKP

K091980Class IIAcl Top 700 LasInstrumentation Laboratory CO / cleared 2009-09-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)