CELL-DYN Emerald Cleaner, product number 09H46-02. 960mL. IVD; Hematology: The CELL-DYN Emerald Cleaner is designed for
FDA device recall Z-1522-2016 · posted 2016-04-19 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories
- Reason for recall
- 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.
- Action taken
- 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
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- GKZ
- Quantity affected
- 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, Philippine
- Date initiated
- 2016-03-24
- Date posted
- 2016-04-19
- Date terminated
- 2017-01-04
- Location
- Santa Clara, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CELL-DYN EMERALD SYSTEM (K081495) | Abbott Laboratories | 2009-02-04 |