Abbott recalls specific lots of Creatine Kinase IVD tests due to stability issues causing error codes and QC failures. Affected units may display "Unable to calculate result" or low quality control results.
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 certain lots of Creatine Kinase IVD tests that may show error codes like "Unable to calculate result" or quality control failures. This could lead to inaccurate test results if used.
The test kits may become unstable over time, causing the device to display error messages about calculation failures or quality control issues. This could result in incorrect test results.
Lab users with the specific lot numbers listed in the recall notice. Those using these tests for medical diagnostics are most at risk of inaccurate results.
Check the lot number on the test kit: 87697UN18 (expires Oct 2018), 99632UN18 (expires Nov 2018), or 24358UN18 (expires Dec 2018). The unique identifier (UDI) starts with (01)00380740012878.
Look for lot numbers 87697UN18, 99632UN18, or 24358UN18 on the test kit.
The test may display "Unable to calculate result, reaction check failure" or quality control results out of range low.
Check the lot number on the test kit: 87697UN18 (expires Oct 2018), 99632UN18 (expires Nov 2018), or 24358UN18 (expires Dec 2018).
The recall does not specify a remedy, so contact Abbott 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-1075-2019 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-1075-2019 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.
