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.
- Company
- Abbott Laboratories
- Recall Initiated
- May 9, 2019
- Terminated
- October 7, 2020
- Recall Number
- Z-0173-2020
- Quantity
- 22 analyzers with tubing
- Firm Location
- Santa Clara, CA
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
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.
Lot / Code Info
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.
Root Cause
Nonconforming Material/Component
Action Taken
The recalling firm issued letters on 5/9/2019 to the consignees who had the installed instruments with the affected serial numbers. The letters were issued via FedEx priority overnight express.