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Terminated

Abbott - CELL-DYN 1800 System with CELL-DYN 22 Calibrators and the CELL-DYN Calibrators and CELL-DYN 16 Controls. Part/Model Number: 07H77-01. Abbott Laboratories, Santa Clara, CA 95054-1113

FDA Recall Z-0455-2008 · Posted 2008-03-13

Recalling FirmAbbott Laboratories
Recall StatusTerminated
Product CodeGKZ
Date Initiated2006-10-27
Date Terminated2011-01-06
Product Quantity4,224 Systems

Reason for Recall

Incorrect Results: Hemoglobin results in donor samples assayed on the CELL-DYN 1800 System vary more than expected across the range of claimed operating temperatures of 18 degrees Celcius to 30 degrees Celcius.

Firm Action

A Product Correction letter was sent to all customers with a reply form on October 27, 2006. Product information letters are being packed with the instrument's accessory kit and with calibrators and quality control products used with the CELL-DYN 1800 System. Correction letters with reply forms have been resent to nonresponding customers.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution, USA and countries of Argentina, Bolivia, Brazil, Canada, Chile, Columbia, Costa Rica, Dominican Republic, El Salvador, Germany, Guatemala, Honduras, Hong Kong, China, Japan, Mexico, Paraguay, Puerto Rico, Singapore, South Korea and Venezuela.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K030513CELL-DYN 1800 SYSTEMAbbott Laboratories · 2003-05-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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