Abbott CELL-DYN Emerald Hematology Analyzer Recall: QC Low Results Risk
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.
Lower-risk recall
There is a potential for the device to generate Quality Control (QC) low or out-of-range low for parameters RBC and PLT.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/68967-abbott-cell-dyn-emerald-hematology-analyzer-recall-qc-low-results.
Source Summary by GovInfoNow · govinfonow.com/recall/68967-abbott-cell-dyn-emerald-hematology-analyzer-recall-qc-low-results · Updated August 20, 2026 · FDA enforcement record: FDA #Z-1074-2019
Cite this page
“Abbott CELL-DYN Emerald Hematology Analyzer Recall: QC Low Results Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/68967-abbott-cell-dyn-emerald-hematology-analyzer-recall-qc-low-results. Based on FDA recall #Z-1074-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1074-2019%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
Abbott- Category
Medical device
What to do — step by step
Check Serial Number
Identify the serial number on the device to determine if it is below 7765.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide Distribution: US (nationwide) including Puerto Rico, and countries of: Argentina, Armenia, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Bangladesh, Barbados, Belgium, Belize, Bermuda, Bosnia and Herzegovina, Brazil,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 2.5 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this device safe to use?
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.
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Where this comes from
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.
- Official source: FDA Recall #Z-1074-2019 (February 20, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1074-2019 to see it in context.
- Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.