Recalling Firm / Manufacturer

Instrumentation Laboratory.

Product

Coagulation Analyzer ACL.

Description

Coagulation Analyzer.

Code Information

ACL ELITEPRO : Serial numbers range 05010100 - 10111779

ACL 10000 : Serial numbers range 0200101 - 06020501

ACL 9000 : Serial numbers range 00040105 - 09031882.

ACL 8000 : Serial numbers range 05010100 - 1011176

ACL ELITE : Serial numbers range 05010100 - 10111176

Reason of Recall

Sporadically lowered APTT results were observed with the PT/APTT Test Groups

Date Recall Initiated

November 8, 2010

Action

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

Contact

Al-Jeel Medical & Trading Co. LTD
Riyadh
(01) 4041717

Source

Product

source

ACL ELITEPRO

FDA

ACL 10000

FDA

ACL 9000

FDA

ACL 8000

FDA

ACL ELITE

FDA

SFDA Comments

SFDA urges all hospitals that have devices subjected to recall, to contact the company.