Z-0173-2020 Class II Terminated
FDA device recall Z-0173-2020 was initiated by Abbott Laboratories on May 9, 2019 and is designated Class II. 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. The recall status is terminated (terminated October 7, 2020). Affected quantity: 22 analyzers with tubing.
Recall Details
- Product Type
- Devices
- Report Date
- October 30, 2019
- Initiation Date
- May 9, 2019
- Termination Date
- October 7, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 22 analyzers with tubing
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.
Distribution Pattern
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.
Code Information
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, 007700, 007701, and 007703.