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U.S. Department of Health and Human Services

Class 2 Device Recall ACL TOP

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  Class 2 Device Recall ACL TOP see related information
Date Initiated by Firm February 22, 2022
Date Posted April 28, 2022
Recall Status1 Open3, Classified
Recall Number Z-1014-2022
Recall Event ID 89894
510(K)Number K160276  
Product Classification Instrument, coagulation, automated - Product Code GKP
Product ACL TOP 300 CTS/350 CTS/500 CTS/550 CTS/970 CL:
Name Part Number
1.ACL TOP 300 CTS 00000280060
2. ACL TOP 300 CTS 00000280060R (Refurbished)
3. ACL TOP 350 CTS 00000280065
4. ACL TOP 500 CTS 00000280040
5. ACL TOP 500 CTS 00000280040R ( Refurbished)
6/
6. ACL TOP 550 CTS 00000280045
7. ACL TOP 970 CL 00000280097
Code Information All Serial Numbers.  Trade Name Part Number UDI  ACL TOP 300 CTS 00000280060 08426950556916;  "ACL TOP 300 CTS (Refurbished)" 00000280060R 08426950928027;  ACL TOP 350 CTS 00000280065 08426950784081;  ACL TOP 500 CTS 00000280040 08426950453499;  "ACL TOP 500 CTS (Refurbished)" 00000280040R 08426950928003;  ACL TOP 550 CTS 00000280045 08426950729242;  ACL TOP 970 CL 00000280097 08430793045476.  
Recalling Firm/
Manufacturer		 Instrumentation Laboratory
180 Hartwell Rd
Bedford MA 01730-2443
For Additional Information Contact SAME
781-861-4467
Manufacturer Reason
for Recall		 Updated and revised user instructions issued 7/14/22. Potential carryover issue may cause elevated quality control and sample results for heparin, apixaban or rivaroxaban when HemosIL Liquid Anti-Xa reagent is used in the same run with both HemosIL Liquid Antithrombin and HemosIL Q.F.A. Thrombin (Bovine), specific to instrument models that utilize a single reagent probe
FDA Determined
Cause 2		 Under Investigation by firm
Action *****UPDATE******PHASE 2 UPDATED - URGENT MEDICAL DEVICE CORRECTION This updated notification is intended to further clarify the Mandatory Customer Actions for the potential carryover issue identified on the following ACL TOP systems (previous URGENT MEDICAL DEVICE CORRECTION letter dated Feb 22, 2022), when running a specific reagent combination. E-mail communication to the Werfen Affiliate and International Group circulated on July 14, 2022. Subsequent investigations have shown that the carryover issue only has the possibility of occurring if QFA Fibrinogen, Liquid Antithrombin, and Liquid Anti-Xa reagent aspirations occur in a specific sequence. " Based on the above, we are revising the instruction to not run HemosIL Liquid Anti-Xa in the same batch as both HemosIL Liquid Antiithrombin and HemosIL Q.F.A. Thrombin (Bovine). Please take one of the following immediate workflows to mitigate this potential carryover issue. " Revised Instructions for Phase 2: 1. Use Separate instruments to run Liquid Anti-Xa and Liquid Antithrombin. 2. Batch Liquid Antithrombin.: Run Liquid Antithrombin tests in isolation (analyzer status starting and ending in a READY state). 3. Batch Anti-Xa, Apixaban and Rivaroxaban testing. Run the maintenance activity Enhanced Clean for Reagent Probe or Enhanced Clean for All Probes from the maintenance menu, then run Liquid Anti-Xa (heparin), apixaban, and rivaroxaban tests in isolation (analyzer status starting and ending in a READY state). Return the completed and signed Mandatory Response Tracking Form to: " Fax No.: 1-781-861-4207 Or E-mail: ra-usa.na@werfen.com For technical questions, please contact the Werfen Technical Support Center at 1-800-678-0710, Option # 1 (ACL Coagulation Products). Previous: PHASE 1: Werfen issued Urgent Field Safety Notification via email /certified mail on 2/22/22. Letter states reason for recall, health risk and action to take: Mandatory Customer Actions Based on the above, please take the following i
Quantity in Commerce 2725 units US: 5,572 units OUS.UPDATE: 2727 units US; 5277 units OUS
Distribution Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belarus, Belgium, Bermuda, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Ecuador, El Salvador, France, Germany, Gibraltar, Great Britain, Greece, Guatemala, Guyana, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Kosovo, Kuwait, Lebanon, Lithuania, Luxembourg, Macau, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, S. Tome, Saudi Arabia, Serbia, Singapore, Slovakia, Spain, Switzerland, Taiwan, Tanzania, Thailand, Trinidad, Tobago, Tunisia, Turkey, United Arab Emirates, Uruguay, Venezuela, Vietnam.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = GKP and Original Applicant = INSTRUMENTATION LABORATORY CO.
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