Abbott recalls The K-ASSAY HP assay kit for updated instructions to ensure accurate haptoglobin testing. No immediate action needed but review instructions for safety.
An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the various products.
Abbott is recalling The K-ASSAY HP assay kit because its instructions need updating to address safety concerns. This update is necessary to ensure accurate haptoglobin testing results without risk.
The kit's instructions require updates to address issues with the reagents and specimen handling. Without these updates, there could be inaccuracies in haptoglobin testing results, but no immediate safety risk is present.
Users of the The K-ASSAY HP assay kit for haptoglobin testing. Those who have the kit and follow the updated instructions are at minimal risk.
The The K-ASSAY HP assay kit from Abbott Laboratories. This product is used for quantitative haptoglobin testing via immunoturbidimetric assay.
Check the kit's instructions for the latest updates to ensure accurate haptoglobin testing.
No immediate danger is present; the recall requires updating instructions for accurate testing.
No, but you should review the updated instructions to ensure accurate results.
No action is needed beyond reviewing the updated instructions for safe use.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-1993-2019 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-1993-2019 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.
