Recall Z-1305-2023
Instrumentation Laboratory · initiated February 3, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
ACL ELITE PRO-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0001000311
Codes / lots: UDI: 08426950451570 Serial Number 23015246 and Prior
Reason for recall
Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments
FDA-determined cause: Device Design
Action taken
Werfen issued UPDATED- URGENT MEDICAL DEVICE REMOVAL MANDATORY TEST LIBRARY UPGRADE to 02.05.00 ACL ELITE/ ELITE PRO HEMOSTASIS TESTING SYSTEMS dated 2/3/23. {This is a follow up to the original notification that advised your facility of the removal of HemosIL Liquid Anti-Xa assay (PN 0020302600/0020302601) on the ACL Elite/Elite Pro system.} Letter states reason for recall, and action to take: The 02.05.00 Mandatory Library release can be installed on ACL Elite/Elite Pro systems, currently running software version 04.00.00 or 03.01.04, with Library 02.03.00 or higher. Any ACL Elite/Elite Pro system running a Test Library prior to 02.03.00 will first require an upgrade to ACL Elite/Elite Pro software 04.00.00 or 03.01.04, with Test Library 02.03.00, before upgrading to Test Library 02.05.00. Your local Werfen representative will install the 02.05.00 Mandatory Test Library at your next scheduled preventative maintenance or service applications visit. If you have any questions or require further assistance, please contact your local representative, or for technical questions, contact Werfen Technical Support Center at 1-800-678-0710, Option # 1 (English), Option # 1 (ACL Hemostasis Products). As part of this same final corrective action phase, test parameters on the ACL TOP Family/ACL TOP Family 50 Series will be released in later Q2 2023, with reduced on-board instrument claims to 4 days. The updates to remove the assay from the ACL Elite/Elite Pro and reduce the on-board instrument stability claims for the ACL TOP Family/ACL TOP Family 50 Series to 4 days is consistent with the FDA clearance under Special 510(k) K213464
Details
- Recall number
- Z-1305-2023
- Initiated
- February 3, 2023
- Posted by FDA
- September 30, 2024
- Product code
- KFF – Assay, Heparin
- Quantity
- 129 units US; 2686 units OUS
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Albania, Algeria, Australia, Austria, Azerbaijan, Belarus, Belgium, Brazil, Bulgaria, Cape Verde, China, Colombia, Czech Republic, Egypt, Falkland Islands, Finland, France, Georgia, Germany, Ghana, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Italy, Japan, Jordan, Kazakhstan, Kenya, Kossovo, Latvia, Lebanon…
- Recalling firm
- Instrumentation Laboratory, Bedford, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1304-2023 Class II | ACL ELITE- Analyzer designed specifically for clinical use in the hemostasis laboratory…Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL… | 02/03/2023Open, Classified |
| Z-1306-2023 Class II | ACL ELITE Refurbished-Analyzer designed specifically for clinical use in the hemostasis…Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL… | 02/03/2023Open, Classified |
| Z-1307-2023 Class II | ACL ELITE PRO Refurbished)-Analyzer designed specifically for clinical use in the…Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL… | 02/03/2023Open, Classified |