FDA Medical Device Recalls (openFDA)
Abbott Laboratories Diagnostic Div: Abbott Clinical Chemistry AEROSET/ ARCHITECT c8000 Creatinine. List No. 7D64-20
- Recall number
- Z-1377-04
- Recalling firm
- Abbott Laboratories Diagnostic Div
- Product
- Abbott Clinical Chemistry AEROSET/ ARCHITECT c8000 Creatinine. List No. 7D64-20
- Status
- Terminated
- Initiated
- 2004-07-27
- Posted
- 2004-08-17
- Terminated
- 2012-05-02
- Reason
- Precipitate formed in product.
- Root cause
- Other
- Action
- Firm sent recall letters requesting destruction of kits in the field on July 27, 2004.
- Quantity
- 758
- Distribution
- Nationwide and to Mexico, Columbia, Ecuador, Brazil, Puerto Rico, Domincan Republic, Canada, Germany, Singapore, Hong Kong, India, Thailand, Australia, New Zealand, Bahamas.
- Lot, serial or model codes
- Lot 14032HW00 Exp November 17, 2005 and lot 17054HW00 Exp November 17, 2005.
- 510(k) numbers
- ["K981799"]
- PMA numbers
- not on file
- Product code
- CGX
- Firm FEI
- 2018433
- Firm city
- South Pasadena
- Firm state
- CA
- 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