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Terminated

Abbott CELL-DYN 3500 Hematology Analyzer

FDA Recall Z-1199-2007 · Posted 2007-08-29

Recalling FirmAbbott Laboratories
Recall StatusTerminated
Product CodeGKZ
Date Initiated2007-05-11
Date Terminated2008-06-19
Product Quantity3,429 units, all models

Reason for Recall

The product failed electrostatic discharge testing, which could result in product failure.

Firm Action

Mandatory Technical Service Bulletins (TSB) are being issued to Field Service to upgrade all instruments in the field. All customers will be contacted by Field Service to schedule this mandatory upgrade. The upgrades are expected to take 12 months.

Root Cause

Other

Distribution Pattern

Worldwide, including USA, Puerto Rico, Canada, Mexico, Argentina, Australia, Bahamas, Brazil, Chile, China, Colombia, Costa Rica, Dominican Republic, El Salvador, Ecuador, Germany, Guatemala, Hong Kong, Jamaica, Japan, New Zealand, Panama, Paraguay, Peru, Singapore, South Korea, Taiwan, Thailand, Uruguay, and Venezuela.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K991605CELL-DYN 3500 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION (IRF), CELL-DYN 3700 SYSTEM WITH IMMATURE RETICULOCYTE FRACTIONAbbott Laboratories · 1999-07-09K980614ABBOTT CELL-DYN 3000 SERIES HEMATOLOGY SYSTEMSAbbott Laboratories · 1998-04-24K955715CELL DYN 3500 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER (MODIFICATION)Abbott Laboratories · 1996-10-08K960427ABBOTT CELL-DYN 3500R SYSTEMSequoia Turner Corp. · 1996-05-02K913305CELL-DYN 3000A MULTI-PARAMETER AUTO HEMA ANALZYERUnipath , Ltd. · 1991-11-22

Official Source

View FDA Recall →

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

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