Generic Name: Blood Coagulation Analyzer — Trade Names: (1) Acl Top 300 Cts — (2) Acl Top 500 Cts — (3) Acl Top 700 Base — (4) Acl Top 700 Cts — (5) Acl Top 700 Las — (6) Acl Top

Recalling firm: Name of Manufacturer/Distributor: I.L. Japan Co., Ltd. — Address of Manufacturer/Distributor: 1-3-30 Mita, Minato-ku, Tokyo — License Type: Type II Medical Device Manufacturer/Distributor —...
Product: Lot: (1)ACL TOP 300 CTS シーティーエス対象台数：33台出荷時期：2012年4月2日〜2020年12月23日対象シリアル： 12030161J, 12030165J, 12030169J, 12060251J, 12060252J, 12060274J, 12070284, 12070288J, 12080298J, 12 100301J, 12110303J, 13020304J, 13020585R, 13030308J, 13030309J, 13030310J, 13030311J, 13040312J, 130 40313J, 13060774, 13060804R, 13070823R, 13100921R, 13121039R, 14011051R, 14031150R, 14061357R, 14091 508R, 15011698R, 15021742, 15031828, 15041861, 15061958 (2)ACL TOP 500 CTS シーティーエス対象台数：22台出荷時期：2010年7月16日〜2016年2月12日対象シリアル： 08040151J, 09010464J, 09070729J, 10061239J, 10061247J, 10091379J, 10101399J, 10101420J,...
Reason: According to an internal investigation by the manufacturer, Instrumentation Laboratories, Inc., carryover occurs when the "Hemos IL Free PS" (in vitro diagnostic medical device, generic name: Protein S Kit, approval number: 21700AMG00002000) is measured in parallel with the "Hemos IL D-Dimer HS500" (in vitro diagnostic medical device, generic name: Fibrin Degradation Product Kit, Approval No.: 225AAAMI00011000) on the aforementioned affected instruments, carryover may occur, potentially resulting in elevated measurement results for “Hemos IL Free PS.” Therefore, test parameters have been...
Classification: Class II
Category: medical device recall
Country: Japan
Agency: PMDA-DEVICE
Status: Ongoing

Recall details on Nibble Recalls: https://trynibble.app/recalls/5a5c47e1-ccf9-4679-ae5c-97a4e060610c