ACL 10000 Coagulation Analyzer, PN 0000100011 Coagulation testing.
This recall has been terminated (originally issued December 27, 2010).
- Company
- Instrumentation Laboratory Co.
- Recall Initiated
- November 11, 2010
- Posted
- December 27, 2010
- Terminated
- August 23, 2013
- Recall Number
- Z-0805-2011
- Quantity
- none in use in US or Canada at this time
- Firm Location
- Bedford, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Sporadically lowered APTT results were observed with the PT/APTT Test Groups.
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.
Lot / Code Info
Serial numbers range 0200101 - 06020501.
Root Cause
Device Design
Action Taken
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.