Abbott Recalls CELL-DYN Emerald Analyzers Due to Quality Control Errors
Abbott Laboratories is recalling 6,353 CELL-DYN Emerald analyzers worldwide because they may generate incorrect low quality control results for red blood cells and platelets.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves potential diagnostic errors without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Abbott Laboratories is recalling 6,353 units of the CELL-DYN Emerald automated hematology analyzer, reference number 09H39-01. The device is intended for in-vitro diagnostic use in clinical laboratories. The recall affects units with serial numbers below 7765.
The recall was initiated because there is a potential for the device to generate Quality Control (QC) low or out-of-range low results for the red blood cell (RBC) and platelet (PLT) parameters. This issue may affect the accuracy of diagnostic testing performed on the affected devices.
The affected units were distributed worldwide, including the United States (nationwide) and Puerto Rico, as well as numerous countries across the Americas, Europe, Asia, Africa, and the Middle East. The source text does not specify specific actions for consumers or healthcare providers beyond the recall notice.
The recalled product
- Product
- CELL-DYN Emerald analyzer, REF 09H39-01. The CELL-DYN Emerald is an automated hematology analyzer intended for in-vitro diagnostic use in the clinical laboratory.
- Manufacturer
- Abbott Laboratories
- Hazard
- Affected units
- 6,353
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All serial numbers below 7765.
Distribution
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