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 C
Check against the official notice below — it lists the full affected range.
Instrumentation Laboratory issued updated and revised user instructions on July 14, 2022, for seven models of ACL TOP laboratory testing instruments (300 CTS, 350 CTS, 500 CTS, 550 CTS, 970 CL, and refurbished versions of the 300 CTS and 500 CTS). The recall addresses a potential carryover issue specific to instrument models that use a single reagent probe. When HemosIL Liquid Anti-Xa reagent is used in the same run together with both HemosIL Liquid Antithrombin and HemosIL Q.F.A. Thrombin (Bovine), the carryover may cause elevated quality control and sample results for heparin, apixaban, or rivaroxaban testing.
Approximately 2,727 units were distributed in the United States and 5,277 units were distributed outside the United States, reaching customers worldwide including Argentina, Australia, Austria, Brazil, Canada, China, France, Germany, Great Britain, India, Japan, Korea, and many other countries. All serial numbers of the affected instruments are included in this recall. The source does not specify what remedy an affected consumer should take.
Written by software from the official notice below. Not reviewed by a lawyer.
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
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 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, Quantity: 2725 units US: 5,572 units OUS.UPDATE: 2727 units US; 5277 units OUS Lot/code info: 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.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.