Instrumentation Laboratory Co. recalls ROTEM ex-tem with US Part No 503-05-US due to prolonged clotting times. Affected units may cause inaccurate blood test results.
Prolonged clotting times
Instrumentation Laboratory Co. is recalling ROTEM ex-tem devices with US Part No 503-05-US because they can cause prolonged clotting times. This may lead to inaccurate blood test results if the device is used improperly.
The device may produce prolonged clotting times when used, leading to inaccurate blood test results. This could affect the accuracy of blood clotting tests, potentially causing incorrect medical decisions.
Healthcare professionals using ROTEM ex-tem devices for blood testing in the United States. Those with the specific US Part No 503-05-US are most at risk.
Check for US Part No 503-05-US on the device. The recall applies to units sold in the United States with Lot # 42255901.
Look for US Part No 503-05-US on the device to confirm if it is affected.
US Part No 503-05-US
The device may cause prolonged clotting times, leading to inaccurate blood test results.
The recall does not mention a remedy or fix.
We’ve drafted a message you can send Instrumentation Laboratory Co. to request your refund or repair — edit it as you like.
Subject: Recall Z-2485-2019 — Instrumentation Laboratory Co. Instrumentation Laboratory Co. Hello, I own a Instrumentation Laboratory Co. that is covered by recall Z-2485-2019 from Instrumentation Laboratory Co.. 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.
