Abbott recalls CELL-DYN Emerald analyzers with serial numbers below 7765 due to potential QC low results for RBC and PLT. Affected units may need correction to avoid inaccurate blood tests.
There is a potential for the device to generate Quality Control (QC) low or out-of-range low for parameters RBC and PLT.
Abbott is recalling CELL-DYN Emerald hematology analyzers with serial numbers below 776:1. These devices may produce inaccurate blood test results if they generate low or out-of-range values for red blood cell and platelet counts.
The device may produce low or out-of-range results for red blood cell (RBC) and platelet (PLT) counts during quality control testing. This could lead to inaccurate blood test results if the analyzer is not properly calibrated or maintained.
Healthcare facilities using CELL-DYN Emerald analyzers with serial numbers below 7765 are affected. Laboratory staff and patients relying on these devices for blood tests are at risk of inaccurate results.
Check the serial number on the CELL-DYN Emerald analyzer. Units with serial numbers below 7765 are affected. The device is sold for clinical laboratory use.
Identify the serial number on the device to determine if it is below 7765.
The recall is due to a potential issue with the device generating low or out-of-range results for red blood cell and platelet counts during quality control testing.
Check the serial number; if it is below 7765, contact Abbott for further instructions.
The device is safe for use but may produce inaccurate results if it generates low or out-of-range values for RBC and PLT. Proper calibration is needed.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-1074-2019 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-1074-2019 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.
