Recall Z-0807-2011 ยท JPA System, Multipurpose For In Vitro Coagulation Studies
Instrumentation Laboratory Co.
ACL ELITE PRO Coagulation Analyzer, PN 00001000311 Coagulation testing.
| Date | Dec 27, 2010 (initiated Nov 11, 2010) |
| Status | Terminated |
| Reason | Sporadically lowered APTT results were observed with the PT/APTT Test Groups. |
| 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 i |
| Quantity | 379 in use in USA & Canada, 24 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, Ho |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060162 | ACL ELITE; ACL ELITE PRO Instrumentation Laboratory CO, Feb 21, 2006 |