Thursday, September 19, 2019

Thursday, September 19, 2019

U.S. FOOD AND DRUG ADMINISTRATION: CELLDYN Emerald Class 2 Device Recall


U.S. Food and Drug Administration recently issued the following announcement. 

Date Initiated by Firm: February 20, 2019

Create Date: March 29, 2019

Recall Status: Open, Classified

Recall Number: Z-1074-2019

Recall Event ID: 82240

510(K)Number: K081495  

Product Classification: Counter, differential cell - Product Code GKZ

Product: CELL-DYN Emerald analyzer, REF 09H39-01.

The CELL-DYN Emerald is an automated hematology analyzer intended for in-vitro diagnostic use in the clinical laboratory.

Code Information: All serial numbers below 7765.

Recalling Firm/Manufacturer: Abbott Laboratories

                                               4551 Great America Pkwy

                                               Santa Clara CA 95054-1208

For Additional Information Contact: Mr. Albert A. Chianello

                                                         877-422-2688

Manufacturer Reason

for RecallThere is a potential for the device to generate Quality Control (QC) low or out-of-range low for parameters RBC and PLT.

FDA Determined Cause: Under Investigation by firm

Action: The recalling firm, Abbott, issued "Product Correction Urgent  Immediate Action Required" letters dated 2/21/2019 via FedEx priority overnight express mail on 2/21/2019 to its customers. The letter described the issue, patient impact, and necessary actions. The customers were instructed to follow the necessary actions and complete and return the Customer Reply form via fax, prior to March 7, 2019 via FAX #: 18007770051 or email QAGCO@abbott.com. Even if you no longer have the instrument(s).

If you or any of the health care providers you serve have any questions regarding this information, U.S. Customers please contact Customer Service at 18774ABBOTT (available 24 hours a day, 7 days a week). Customers outside the U.S., please contact your local area Customer Service.

Quantity in Commerce: 6,353 units

Distribution: Worldwide Distribution: US (nationwide) including Puerto Rico, and countries of: Argentina, Armenia, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Bangladesh, Barbados, Belgium, Belize, Bermuda, Bosnia and Herzegovina, Brazil, Bulgaria, Burkina Faso, Cameroon, Canada, Chile, China, Colombia, Congo, Costa Rica, Croatia, Cyprus, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvador, Ethiopia, Finland, France, Gaza & Jericho, Germany, Greece, Guatemala, Guinea, Haiti, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Ivory Coast, Jamaica, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Mali, Mauritania, Mexico, Moldova, Montenegro, Mozambique, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, St. Maarten, St. Vincent & The Grenadines, Sudan, Switzerland, Taiwan, Tanzania, Thailand, Togo, Trinidad & Tobago, Turkey, Turks & Caicos, UAE, Uganda, UK, Uruguay, Venezuela, Viet Nam, Yemen, Zambia, and Zimbabwe.

Total Product Life Cycle: TPLC Device Report

Original source can be found here.

Organizations in this Story

U.S. Food and Drug Administration

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