Instrumentation Laboratory Co. recalls ROTEM ex-tem Rest of the world part 503-05 (ROW) due to prolonged clotting times. Affected units include lot #42255701.
Prolonged clotting times
Instrumentation Laboratory Co. is recalling ROTEM ex-tem Rest of the world part 5: 503-05 (ROW) because it can cause prolonged clotting times. This may lead to health risks if the device is used incorrectly.
The device part can cause prolonged clotting times, which may lead to inaccurate blood test results. This could result in improper medical decisions if the device is used without proper calibration.
Users of the ROTEM ex-tem device with the specified part number are affected. Healthcare professionals who rely on this device for blood testing are most at risk.
Check for the part number 503-05 (ROW) on the device. Affected units were sold with lot number 42255701.
Look for the part number 503-05 (ROW) on the device to confirm if it is affected.
The recalled part number is 503-05 (ROW).
Lot number 42255701 is affected.
The recall record does not specify a remedy.
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-2487-2019 — Instrumentation Laboratory Co. Instrumentation Laboratory Co. Hello, I own a Instrumentation Laboratory Co. that is covered by recall Z-2487-2019 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.
