FDA Medical Device Recalls (openFDA)
Abbott Laboratories, Inc: Aeroset Analyzer, item 9D05-01
- Recall number
- Z-0843-03
- Recalling firm
- Abbott Laboratories, Inc
- Product
- Aeroset Analyzer, item 9D05-01
- Status
- Terminated
- Initiated
- 2001-10-02
- Posted
- 2003-05-20
- Terminated
- 2004-04-07
- Reason
- Extensive use of cuvettes causes inaccurate results. Preventative maintenance did not specify replacement schedule.
- Root cause
- Other
- Action
- The firm issued a letter to affected consignees on or about 10/02/2001 notifying the consignees that an Abbott Field Representative will perform a one-time cuvette upgrade to the consignee''s AEROSET system.
- Quantity
- 238 units
- Distribution
- Nationwide and to the following foreign countries: Mexico, Guatemala, Venezuela, Columbia, Argentina, Brazil, Dominican Republic, Canada, Germany, Hong Kong, Australia, New Zealand, China, England
- Lot, serial or model codes
- All units on the market prior to 12/3/2001.
- 510(k) numbers
- ["K980367"]
- 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
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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