Z-2389-2012Class II

Instrumentation Laboratory ACL TOP CTS PN 0000280020 ACL TOP is a bench top, fully automated, random access...

Name: Z-2389-2012 Instrumentation Laboratory ACL TOP CTS PN 0000280020 ACL TOP is a bench top, fully automated, random access...
Creator: Instrumentation Laboratory Co.
Published: 2012-08-03
License: https://open.fda.gov/license/

Instrumentation Laboratory Co. / initiated 2012-08-03 / Terminated / root cause: software

FDA source

Instrumentation Laboratory Co. began a recall of Instrumentation Laboratory ACL TOP CTS PN 0000280020 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro... on 2012-08-03. FDA classified it as Class II and gives the reason as "Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2389-2012
Classification: Class II
Status: Terminated
Initiated: 2012-08-03
Posted: 2012-09-14
Terminated: 2015-10-02
Recalling firm: Instrumentation Laboratory Co.
Product: Instrumentation Laboratory ACL TOP CTS PN 0000280020 ACL TOP is a 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: Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low
Root cause tag: software
FDA root cause: Software design
Action: The firm, Instrumentation Laboratory, sent a "Mandatory Test Parameter Upgrade" letter dated June 7, 2012 with upgrade kits P-14.8 via USPS on August 3 thru August 10 to US and Canadian customers and notified International Affiliates via e-mail on August 2, 2012. The customers were ask to complete and return the Mandatory Test Parameter Upgrade Tracking Form via fax: 781-861-4207 or email: [email protected]. If you have any questions, call 781-861-4204.
Quantity in commerce: 562 units
Distribution: Worldwide distribution: USA (nationwide) and countries of: ARGENTINA, AUSTRALIA, AUSTRIA, BELARUS, BELGIUM, BRAZIL, BRUNEI DARUSSALAM, BULGARIA, CHILE, CHINA, DENMARK, FINLAND, FRANCE, GERMANY, HONG KONG, HUNGARY, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, KOREA, REPUBLIC OF LUXEMBOURG, MACAU, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, PANAMA, PERU, POLAND, PORTUGAL, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SLOVAKIA (Slovak Republic), SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, PROVINCE OF CHINA, THAILAND, TURKEY, UNITED KINGDOM, URUGUAY and VIETNAM.
Product codes and lots: Serial Number range: 06020101 through 10080662 Distributed between: Feb 2006 to Aug 2010

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2389-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2387-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-26	2012-09-14
Z-2388-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-26	2012-09-14
Z-2389-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-26	2012-09-14
Z-2390-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-26	2012-09-14
Z-2391-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-26	2012-09-14
Z-2392-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-26	2012-09-14

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)