Recalls / —
—#176376
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.
- FDA product code
- GKZ — Counter, Differential Cell
- Device class
- Class 2
- Medical specialty
- Hematology
- 510(k) numbers
- K081495
- Affected 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.
Why it was 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.
Root cause (FDA determination)
Nonconforming Material/Component
Action the firm took
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.
Recalling firm
- Firm
- Abbott Laboratories
- Address
- 4551 Great America Pkwy, Santa Clara, California 95054-1208
Distribution
- 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.
Timeline
- Recall initiated
- 2019-05-09
- Terminated
- 2020-10-07
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #176376. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.