FDA Medical Device Recalls (openFDA)
Abbott Laboratories, Inc: AxSYM Analyzer, Small Heater Block Clamp, manufactured by Abbott Laboratories, Irving, Texas
- Recall number
- Z-0173-04
- Recalling firm
- Abbott Laboratories, Inc
- Product
- AxSYM Analyzer, Small Heater Block Clamp, manufactured by Abbott Laboratories, Irving, Texas
- Status
- Terminated
- Initiated
- 2002-06-06
- Posted
- 2004-07-20
- Terminated
- 2004-08-09
- Reason
- 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.
- Root cause
- Other
- 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.
- Quantity
- 15437 units worldwide
- Distribution
- 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
- Lot, serial or model codes
- All Serial Numbers
- 510(k) numbers
- ["K974651"]
- PMA numbers
- not on file
- Product code
- JJE
- Firm FEI
- 1628664
- Firm city
- Irving
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28