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.
Reported: October 30, 2019 Initiated: May 9, 2019 #Z-0173-2020
Product Description
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.
Reason for Recall
The diluent tubing used on the instrument appears cloudy or to have a powder/film on the inner and outer surfaces which may result in falsely elevated platelet results.
Details
- Recalling Firm
- Abbott Laboratories
- Units Affected
- 22 analyzers with tubing
- Distribution
- Distribution was made to GA, LA, MA, NC, NY, SC, and TX. There was no military/government distribution. Foreign distribution was made to Australia, Germany, Greece, Honduras, Indonesia, Italy, and Serbia.
- Location
- Santa Clara, CA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Abbott Laboratories. Units affected: 22 analyzers with tubing.
Why was this product recalled? ▼
The diluent tubing used on the instrument appears cloudy or to have a powder/film on the inner and outer surfaces which may result in falsely elevated platelet results.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 30, 2019. Severity: Moderate. Recall number: Z-0173-2020.
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