Z-2061-2014Class II

ACL TOP 700, automated coagulation laboratory instrument

Name: Z-2061-2014 ACL TOP 700, automated coagulation laboratory instrument
Creator: Instrumentation Laboratory Co.
Published: 2014-06-03
License: https://open.fda.gov/license/

Instrumentation Laboratory Co. / initiated 2014-06-03 / Terminated / root cause: design

FDA source

Instrumentation Laboratory Co. began a recall of ACL TOP 700, automated coagulation laboratory instrument on 2014-06-03. FDA classified it as Class II and gives the reason as "Potential for sample misidentification". 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-2061-2014
Classification: Class II
Status: Terminated
Initiated: 2014-06-03
Posted: 2014-07-16
Terminated: 2017-09-21
Recalling firm: Instrumentation Laboratory Co.
Product: ACL TOP 700, automated coagulation laboratory instrument.
Product code: GKP Instrument, Coagulation, Automated
Reason for recall: Potential for sample misidentification.
Root cause tag: design
FDA root cause: Device Design
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.
Quantity in commerce: 633
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, 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.
Product codes and lots: Start SN and Date: 09080100 Aug 2009 and End SN and Date 14050732 May 2014

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2061-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2060-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-23	2014-07-16
Z-2061-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-23	2014-07-16
Z-2062-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-23	2014-07-16
Z-2063-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-23	2014-07-16
Z-2064-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-23	2014-07-16
Z-2065-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-23	2014-07-16
Z-2066-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-23	2014-07-16

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)