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 000002

FDA device recall Z-1014-2022 · posted 2022-04-28 · Open, Classified

Recall details

Recalling firm

Instrumentation Laboratory

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

Action taken

*****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

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

GKP

Quantity affected

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, Ecua

Date initiated

2022-02-22

Date posted

2022-04-28

Location

Bedford, MA

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