Abbott Recalls CELL-DYN Emerald Cleaner Due to Analyzer Quality Control Issues
Abbott Laboratories is recalling CELL-DYN Emerald Cleaner because it may cause the hematology analyzer to generate out-of-range quality control results for RBC and PLT.
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 (out-of-range quality control) rather than direct physical injury or reported illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Abbott Laboratories is recalling CELL-DYN Emerald Cleaner, product number 09H46-02, 960mL. This product is an enzymatic cleaner designed for use on the CELL-DYN Emerald System, an automated hematology analyzer used in clinical laboratories for in-vitro diagnostic testing.
The recall was initiated because three lots of the cleaner may cause the analyzer to generate Quality Control Out of Range Low results for the parameters RBC (Red Blood Cells) and PLT (Platelets). The recall has been expanded to include additional lots and units as identified by the firm.
The affected product was distributed worldwide, including the United States (nationwide) and Puerto Rico, as well as numerous international countries. Clinical laboratories and healthcare facilities should stop using the affected lots and contact Abbott Laboratories for further instructions or replacement.
The recalled product
- Product
- CELL-DYN Emerald Cleaner, product number 09H46-02. 960mL. IVD; Hematology: The CELL-DYN Emerald Cleaner is designed for use on the CELL-DYN Emerald System, which is an automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories. The…
- Manufacturer
- Abbott Laboratories
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 (20)
- Lot 6853
- Expiration date: 31 JUL2017
- Lot 6901
- Expiration date: 31JUL2017
- Lot 6953
- Expiration date: 30SEP2017
- May 4
- Expiration date: 30NOV2017
- Lot 7024
- Expiration date: 31DEC2017
- Lot: 7027
- Expiration date: 31DEC2017. June 28
- 2016 - firm added an additional 4 lots to recall: Lot 7044
- expiration date 31JAN2018
- Lot 7082
- expiration date 28FEB2018
- Lot 7110
- expiration date 31MAR2018
- Lot 7119
- expiration date 30APR2018.
Distribution
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