Abbott recalls ARCHITECT Creatine Kinase IVD with potential stability issues causing error codes and QC failures. Affected units include specific lot numbers and expiration dates.
The product has a stability issue which may lead to an error code indicating "Unable to calculate result, reaction check failure" and/or Quality Control results out of range low.
Abbott is recalling its ARCHITECT Creatine Kin:ase IVD test kit due to stability problems that might cause error messages or inaccurate quality control results. This could lead to incorrect test outcomes if the device is used without proper calibration.
The test kit may become unstable over time, leading to error messages like 'Unable to calculate result, reaction check failure' or quality control results showing values outside the acceptable range. This could result in inaccurate test results if the device is used without proper calibration.
Healthcare professionals using the Abbott ARCHITECT Creatine Kinase test kit are most at risk, particularly those who rely on the device for accurate diagnostic results. The recall affects specific lot numbers and expiration dates.
Check for the lot number 99633UN18 with expiration date 02JAN19 on the product label. The unique device identifier (UDI) starts with (01)00380740101176(17)190102(10).
Look for the lot number 99633UN18 and expiration date 02JAN19 on the device label.
The recall is for potential stability issues that could cause error messages or inaccurate quality control results, but it does not pose a direct risk of injury or serious harm.
Check for the lot number 99633UN18 with expiration date 02JAN19 and the unique device identifier starting with (01)00380740101176(17)190102(10).
The recall does not specify a remedy, so contact Abbott directly for guidance on next steps.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-1076-2019 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-1076-2019 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.
