Instrumentation Laboratory recalls ACL TOP 300 CTS/350 CTS/500 CTS/550 CTS/970 CL analyzers due to potential elevated results for heparin, apixaban, or rivaroxaban when used with specific reagents. Affected units have serial numbers listed in the recall notice.
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
Instrumentation Laboratory is recalling several blood analyzer models because using them with certain reagents may cause inaccurate test results for specific medications. This could lead to incorrect medical decisions if the results are not properly interpreted.
The analyzers may produce elevated results for heparin, apixaban, or rivaroxaban when used with specific reagents in the same test run. This could lead to incorrect medical decisions if the results are not properly interpreted.
Users of the ACL TOP 300 CTS, 350 CTS, 500 CTS, 550 CTS, and 970 CL analyzers with serial numbers listed in the recall notice. Laboratory staff and healthcare professionals who perform blood tests are most at risk.
Check the serial number on your analyzer. Affected models include ACL TOP 300 CTS, 350 CTS, 500 CTS, 550 CTS, and 970 CL with specific serial numbers listed in the recall notice.
Look for the serial number on your analyzer to determine if it is affected by this recall.
The recall is due to a potential carryover issue that may cause elevated results for heparin, apixaban, or rivaroxaban when using specific reagents in the same test run.
Check the serial number on your analyzer to see if it is affected. If it is, you should contact Instrumentation Laboratory for further instructions.
Yes, the affected models are ACL TOP 300 CTS, 350 CTS, 500 CTS, 550 CTS, and 970 CL with specific serial numbers listed in the recall notice.
We’ve drafted a message you can send Instrumentation Laboratory to request your refund or repair — edit it as you like.
Subject: Recall Z-1014-2022 — Instrumentation Laboratory Instrumentation Laboratory Hello, I own a Instrumentation Laboratory that is covered by recall Z-1014-2022 from Instrumentation Laboratory. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
