Recall Z-1522-2016 ยท GKZ Counter, Differential Cell
Abbott Laboratories
CELL-DYN Emerald Cleaner, product number 09H46-02. 960mL. IVD; Hematology: The CELL-DYN Emerald Cleaner is designed for use on the CELL-DYN Emerald System, which is an automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories. The CELL-DYN Emerald Cleaner is an enzymatic cleaner used to clean the measurement system and the fluidics.
| Date | Apr 19, 2016 (initiated Mar 24, 2016) |
| Status | Terminated |
| Reason | Three lots of CELL-DYN Emerald Cleaner may have occurrences where the analyzer generates Quality Control Out of Range Low for parameters RBC and PLT. |
| Root cause | Under Investigation by firm |
| Action | All customers who were shipped the affected lots were sent a Product Recall letter on March 24, 2016 via Federal Express. Letters were titled Product Recall - Immediate Action Required. An additional four lots were discovered to be affected by the recall and the firm send letters to customers affected by these lots on June 27, 2016 |
| Quantity | 10,364 plus 9410 additional units for recall expansion. |
| Distribution | Worldwide Distribution-US (nationwide) including Puerto Rico and the countries of Austria, Bosnia & Herze, Cameroon, Egypt, Germany, Indonesia, Iraq, Lebanon, Mali, Montenegro, Netherlands, Philippines, Tanzania, Thailand, UAE, New Zealand, Malaysia, Mexico, South Korea, Jamaica, Turks & Caicos, It |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081495 | CELL-DYN EMERALD SYSTEM Abbott Laboratories, Feb 4, 2009 |