Abbott recalls ARCHITECT STAT High Sensitive Troponin-I Controls due to delivery without required dry ice. This may affect test accuracy and require replacement.
Devices were delivered without the required dry ice.
Abbott is recalling ARCHITECT STAT High Sensitive Troponin-I Controls because they were delivered without the required dry ice. This could lead to inaccurate test results if used without proper cold chain handling.
The controls were delivered without dry ice, which is necessary for maintaining the correct temperature during transport. Without dry ice, the controls may not remain at the required temperature, leading to inaccurate test results.
Users of the ARCHITECT STAT High Sensitive Troponin-I Controls for cardiac troponin I testing are affected. Laboratories using these controls for clinical testing are most at risk.
Check for the product name 'ARCHITECT STAT High Sensitive Troponin-I Controls' and lot number 94347UIOO. The recall applies to units delivered without dry ice.
Verify the lot number on the control vial; affected units have lot number 94347UIOO.
If the controls were delivered without dry ice, replace them with a new batch from Abbott.
Dry ice is required to maintain the correct temperature during transport. Without it, the controls may not remain at the required temperature, leading to inaccurate test results.
Check for the lot number 94347UIOO on the control vial. The recall applies to units delivered without dry ice.
No, but if you have the recalled lot number, you should replace them with a new batch to ensure accurate test results.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-1359-2019 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-1359-2019 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.
