CELL-DYN Diluent/Sheath Reagent, for use with CELL-DYN Ruby, Sapphire and 4000 systems. List #01H73-01. Packaged in 20 Liter cubitainers.
FDA Recall Z-0565-2007 · Posted 2007-03-01
Recalling FirmAbbott Laboratories
Recall StatusTerminated
Product CodeGIF
Date Initiated2006-12-22
Date Terminated2007-11-28
Product Quantity652 (20 L. each) cubitainers
Reason for Recall
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.
Firm Action
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.
Root Cause
Other
Distribution Pattern
Nationwide, including California and Nevada. An Abbott Laboratories facility in Hong Kong.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.