Recalls / —
—#50158
Product
CELL-DYN Diluent/Sheath Reagent, for use with CELL-DYN Ruby, Sapphire and 4000 systems. List #01H73-01. Packaged in 20 Liter cubitainers.
- FDA product code
- GIF — Diluent, Blood Cell
- Device class
- Class 1
- Medical specialty
- Hematology
- 510(k) numbers
- K051215, K061667, K961439
- Affected lot / code info
- Lot Number 42063I2, List Number 01H73-01
Why it was recalled
Results for tests of RBC, MCV, RDW, MPV and PLT may be falsely elevated or falsely decreased when the Cell Dyn Diluent/Sheath reagent is used with Cell-Dyn 4000, Ruby and Sapphire systems.
Root cause (FDA determination)
Other
Action the firm took
Recall initated 12/22/2006. Product letters were sent to consignees, as well as a customer reply form. The letters were sent with customer reply forms. Responses will be tracked via the response forms included with letters.
Recalling firm
- Firm
- Abbott Laboratories
- Address
- 5440 Patrick Henry Dr, Santa Clara, California 95054-1113
Distribution
- Distribution pattern
- Nationwide, including California and Nevada. An Abbott Laboratories facility in Hong Kong.
Timeline
- Recall initiated
- 2006-12-22
- Posted by FDA
- 2007-03-01
- Terminated
- 2007-11-28
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #50158. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.