Instrumentation Laboratory recalls ACL TOP Family 50 Series models for potential sample misidentification in hemostasis labs, risking incorrect patient results. Affected units include specific models and software versions.
Sample misidentification could occur under specific conditions and patient management altered based on an incorrectly assigned result
Instrumentation Laboratory is recalling its ACL TOP Family 50 Series models used for coagulation testing. The recall is due to a risk of sample misidentification, which could lead to incorrect patient results if not properly managed.
The device could misidentify samples under specific conditions, leading to incorrect patient results. This might cause inappropriate treatment decisions if healthcare providers rely on the wrong test outcomes.
Healthcare professionals using these devices in hemostasis laboratories for coagulation testing. Patients receiving results from these devices may be at risk of incorrect management if the device misidentifies samples.
Check for the model numbers listed: ACL TOP 550 CTS (00000280045), ACL TOP 750 CTS (00000280055), ACL TOP 350 CTS (00000280065), ACL TOP 750 (00000280015), ACL TOP 750 LAS (00000280035), and ACL TOP 970 CL (00000280097). Also, verify the software version is v6.3.0 or later for the 50 Series models.
Identify your device model and software version to confirm if it's affected by this recall.
Reach out to Instrumentation Laboratory for specific guidance on the recall and next steps.
The affected models include ACL TOP 550 CTS, ACL TOP 750 CTS, ACL TOP 350 CTS, ACL TOP 750, ACL TOP 750 LAS, and ACL TOP 970 CL with specific model numbers and software versions.
The device might misidentify samples, leading to incorrect patient results and potentially inappropriate treatment decisions.
No, the recall does not require immediate discontinuation. However, you should check if your device is affected and contact the manufacturer for guidance.
We’ve drafted a message you can send Instrumentation Laboratory to request your refund or repair — edit it as you like.
Subject: Recall Z-2578-2023 — Instrumentation Laboratory Instrumentation Laboratory Hello, I own a Instrumentation Laboratory that is covered by recall Z-2578-2023 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.
