Abbott Recalls Emerald Diluent Tubing Due to Cloudiness and Film
Abbott Laboratories is recalling 22 CELL-DYN Emerald analyzers with diluent tubing that appears cloudy or has a film, which may cause falsely elevated platelet results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of harm (falsely elevated platelet results) where no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Abbott Laboratories is recalling 22 CELL-DYN Emerald analyzers equipped with Emerald Diluent Tubing (List number 09H50-01). The recall involves specific instrument serial numbers and tubing lot #2018-10-16. The affected products were distributed to laboratories in Georgia, Louisiana, Massachusetts, North Carolina, New York, South Carolina, and Texas, as well as to locations in Australia, Germany, Greece, Honduras, Indonesia, Italy, and Serbia.
The recall was initiated because the diluent tubing appears cloudy or has a powder/film on the inner and outer surfaces. This condition may result in falsely elevated platelet results. The agency has classified this as a Class II recall.
Users of the affected instruments should contact Abbott Laboratories for instructions on how to proceed. The recall number is Z-0173-2020.
The recalled product
- Product
- Emerald Diluent Tubing, List number 09H50-01, accompanying CELL-DYN Emerald instrument, List number 09H39-01. The firm name on the label is Abbott Laboratories, Abbott Park, IL.
- Manufacturer
- Abbott Laboratories
- Hazard
- Affected units
- 22
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)
- Tubing lot #2018-10-16
- Instrument serial numbers 007689
- 007690
- 007691
- 007692
- 007705
- 007706
- 007707
- 007708
- 007709
- 007728
- 007694
- 007695
- 007697
- 007766
- 007767
- 007768
- 007765
- 007710
- 007699
Distribution
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