Abbott recalls ARCHITECT Sirolimus Calibrators delivered without dry ice. These devices may not calibrate properly. Affected units have lot number 46K15718.
Devices were delivered without the required dry ice.
Abbott is recalling ARCHITECT Sirolimus Calibrators that were delivered without the required dry ice. This could cause improper calibration of sirolimus tests in blood samples.
The calibrators require dry ice to maintain proper temperature during shipping. Without dry ice, the devices may not calibrate correctly, leading to inaccurate sirolimus test results.
Healthcare facilities using these calibrators for sirolimus testing in blood samples. Patients receiving tests with improperly calibrated devices may have inaccurate results.
Check for lot number 46K15718 on the packaging. These calibrators were delivered without dry ice and are used with the ARCHITECT iSystem for sirolimus testing.
Look for lot number 46K15718 on the packaging to confirm if your device is affected.
Dry ice is required to maintain the proper temperature during shipping. Without it, the calibrators may not function correctly.
The calibrator may not calibrate properly, leading to inaccurate sirolimus test results in blood samples.
Check for lot number 46K15718 on the packaging. These calibrators were delivered without dry ice.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-1355-2019 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-1355-2019 from Abbott. 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.
