FDA Medical Device Recalls (openFDA)
Abbott Laboratories HPD/ADD/GPRD: TDx/TDxFLx C-Reactive Protein (CRP) Reagents, list 9550-60; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064
- Recall number
- Z-0507-04
- Recalling firm
- Abbott Laboratories HPD/ADD/GPRD
- Product
- TDx/TDxFLx C-Reactive Protein (CRP) Reagents, list 9550-60; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064
- Status
- Terminated
- Initiated
- 2003-12-05
- Posted
- 2004-02-04
- Terminated
- 2005-04-25
- Reason
- The reagent package inserts for the products contain incorrect information in the Specific Performance Characteristics section. Accuracy by Correlation table
- Root cause
- Other
- Action
- Field Correction recall by Important Product Information letter dated 12/5/03, sent via Federal Express Priority on the same date to all customers receiving the affected reagents. The accounts were informed of the incorrect values for the Specific Performance Characteristics listed in the package inserts of the reagent kits. The letters contained a table listing the incorrect values and the correct values for each of the products, and the users were instructed to replace their product inserts with the enclosed revised package inserts for all product specific reagent kits in their laboratory.
- Quantity
- 1,644 kits
- Distribution
- Nationwide and internationally through Abbott subsidiaries in Mexico, Guatemala, Colombia, Chile, Argentina, Brazil, Puerto Rico, San Salvador, Canada, England, Japan, Singapore, Hong Kong, Taiwan, Thailand, Korea, Australia, New Zealand, Honduras, Costa Rica, Bahamas, Panama, Dominican Republic and China.
- Lot, serial or model codes
- All lots with insert version 66-9771/R3. The corrected insert is version 34-2897/R4.
- 510(k) numbers
- ["K854542"]
- PMA numbers
- not on file
- Product code
- DCK
- Firm FEI
- 1415939
- Firm city
- Abbott Park
- Firm state
- IL
- 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