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Terminated

AxSYM Analyzer, Small Heater Block Clamp, manufactured by Abbott Laboratories, Irving, Texas

FDA Recall Z-0173-04 · Posted 2004-07-20

Recalling FirmAbbott Laboratories, Inc
Recall StatusTerminated
Product CodeJJE
Date Initiated2002-06-06
Date Terminated2004-08-09
Product Quantity15437 units worldwide

Reason for Recall

Clamp can cause misaligned seating of heater block resulting in inaccurate dispension of MEIA Wash Buffer or MUP into the reaction cell. Causes inconsistent results.

Firm Action

All consignees received Technical Service Bulletin (TSB) #83-081. This TSB gave instructions on how to install the AxSYM Small Heater Block clamp upgrade implemented June 6, 2002.

Root Cause

Other

Distribution Pattern

Nationwide and to the following foreign locations: Mexico, Viet Nam, Venezuela, Columbia, Argentina, Chile, Japan, Austria, Denmark, France, Israel, Norway, Saudi Arabia, Spain, Turkey, India, Phillippines, Brazil, Puerto Rico, Dominicam Republic, Canada, Germany, Taiwan, Thailand, Belgium, Egypt, Greece, Italy, Poland, South Africa, Sweden, United Arab Emirates, Malaysia, Singapore, Hong Kong, Australia, New Zealand, China, Uruguay, Korea, England, Czech Republic, Finland, Hungary, Netherlands, Portugal, Eastern Europe, Switzerland, Central America, and Pakistan

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K974651ABBOTT AXSYM SYSTEMAbbott Laboratories · 1998-02-12

Official Source

View FDA Recall →

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

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