Abbott brand CELL-DYN Emerald Hematology Analyzer System; List Numbers: 09H39-01; The product is manufactured in France

FDA device recall Z-1733-2011 · posted 2011-03-18 · Terminated

Recall details

Recalling firm

Abbott Laboratories

Reason for recall

Abbott has determined that gain settings for the non-standard specimen types may not match the gain settings for the standard specimen type. There is the potential for impact to product performance.

Action taken

The firm, Abbott, sent two "Product Correction" letters one dated March 23,2010 and a follow-up letter dated July 1, 2010, via express mail to all its consignees/customers. The letters described the product, problem and actions to be taken. The customers were instructed to perform the following steps, noted in the letter, to print and verify their gain setting. Abbott informed the customers that they would receive a mandatory software update and were instructed to install the CELL-DYN Emerald according to the attached instructions, and to complete and return the Customer Reply form via fax to 1-800-777-0051 or email to QAGCO@abbott.com. Should you have any questions or would like to discuss in more detail, contact Director Quality Assurance and Regulatory Affairs Abbott Hematology at 408-567-3403.

Root cause

Software design (manufacturing process)

Status

Terminated

Product code

GKZ

Quantity affected

891 units

Distribution

Worldwide distribution: USA including: AK, AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, and WV; and count

Date initiated

2010-03-23

Date posted

2011-03-18

Date terminated

2011-03-18

Location

Santa Clara, CA

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