Z-0806-2011

ACL ELITE Coagulation Analyzer, PN 00000880311 Coagulation testing

Name: Z-0806-2011 ACL ELITE Coagulation Analyzer, PN 00000880311 Coagulation testing
Creator: Instrumentation Laboratory Co.
Published: 2010-11-11
License: https://open.fda.gov/license/

Instrumentation Laboratory Co. / initiated 2010-11-11 / Terminated / root cause: design

FDA source

Instrumentation Laboratory Co. began a recall of ACL ELITE Coagulation Analyzer, PN 00000880311 Coagulation testing on 2010-11-11. The reason FDA records is "Sporadically lowered APTT results were observed with the PT/APTT Test Groups". 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-0806-2011
Status: Terminated
Initiated: 2010-11-11
Posted: 2010-12-27
Terminated: 2013-08-23
Recalling firm: Instrumentation Laboratory Co.
Product: ACL ELITE Coagulation Analyzer, PN 00000880311 Coagulation testing.
Product code: JPA System, Multipurpose For In Vitro Coagulation Studies
Reason for recall: Sporadically lowered APTT results were observed with the PT/APTT Test Groups.
Root cause tag: design
FDA root cause: Device Design
Action: On 11/11/10, An Urgent Product Notification informing customers to discontinue use of all IL locked PT/APTT-based Test Groups was mailed to U.S. and Canadian customers, instructing them to run in Single Test or Profile Mode until further notice. The letter identified the affected product, the issue, risk and stated a list of mandatory actions. Customers are to immediately acknowledge the receipt of the notification by signing and returning it via email or fax. A Worldwide Regulatory Notice was sent on November 8, 2010 to international affiliates (non-U.S. or Canada), notifying them of the issue, providing a risk summary and the support documentation for the notification. Secondary international dealers were notified Nov 8 and a fax response of notification of the dealers will be tracked by International Laboratories. The customer notification of the secondary dealers will be handled per the local regulatory requirements of the countries where they are located.
Quantity in commerce: 514 distributed in USA & Canada, 55 in distribution channel subject to recall
Distribution: Worldwide Distribution -- USA, Canada, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Sri Lanka, Sweden, Thailand, Trinidad & Tobago, Tunisia, Turkey, Turkmenistan, United Arabian Emirates, Uruguay, Venezuela, Vietnam, Austria, Belgium, China, France, Germany, Holland, Italy, Japan, Spain (and Portugal), and UK.
Product codes and lots: Serial numbers range 05010100 - 10111176.

Product code JPA

K060162Class IIAcl Elite; Acl Elite ProInstrumentation Laboratory CO / cleared 2006-02-21

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)