Abbott brand CELL-DYN Emerald, CELL-DYN Emerald CPU Board Hematology System; List Number: 09H39-01; Field Replaceable Un
FDA device recall Z-1094-2011 · posted 2011-02-10 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories
- Reason for recall
- There is the potential for the instrument to not power up due to the flash memory issue. This will result in an error message displayed is "No Memory Available" and has the potential for delay in generating patient results.
- Action taken
- The firm, Abbott Laboratories, sent a "Product Correction" letter dated October 15, 2010 to all customers. The letter described the product, problem and action to be taken by the customer. The customers were instructed to install a new printer driver in the software location using the provided instructions and to complete and return the Customer Reply Form via fax 1-800-777-0051 or email to QAGCO@abbott.com even if they no longer have the instrument. If you have any questions regarding this information, U.S. customers should call Customer Support at 1-877-4ABBOTT; customers outside the U.S., please contact your local hematology customer support representative.
- Root cause
- Other
- Status
- Terminated
- Product code
- GKZ
- Distribution
- Worldwide distribution: USA including states of: AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, O, OR, PA, RI, SC, TN, TX, UT, VA, W
- Date initiated
- 2010-10-15
- Date posted
- 2011-02-10
- Date terminated
- 2011-06-07
- Location
- Santa Clara, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CELL-DYN EMERALD SYSTEM (K081495) | Abbott Laboratories | 2009-02-04 |