Instrumentation Laboratory Co. recalls ROTEM ex-tem Canada Part No 503-05-CA with Lot # 42255801 due to prolonged clotting times. Affected users should contact for remedy.
Prolonged clotting times
Instrumentation Laboratory Co. is recalling ROTEM ex-tem Canada Part No 503-0: 5-CA with Lot # 422: 55801 because it may cause prolonged clotting times. This could lead to health risks if used incorrectly.
Prolonged clotting times can cause blood to take longer to clot than normal, potentially leading to excessive bleeding or health complications. This risk is specific to the device's performance in certain medical testing scenarios.
Healthcare professionals using the ROTEM ex-tem device in Canada are most at risk. Patients receiving blood tests with this device may also be affected.
Check for the Canada Part No: 503-05-CA and Lot # 42255801 on the device. The recall applies to devices sold in Canada.
Reach out to Instrumentation Laboratory Co. for specific instructions on the remedy.
The recall states there is a risk of prolonged clotting times, but the exact danger level is not specified in the record.
Look for Canada Part No: 503-05-CA and Lot # 42255801 on the device. The recall applies to devices sold in Canada.
The official notice does not specify a remedy, so contact Instrumentation Laboratory Co. for instructions.
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-2486-2019 — Instrumentation Laboratory Co. Instrumentation Laboratory Co. Hello, I own a Instrumentation Laboratory Co. that is covered by recall Z-2486-2019 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.