FDA Medical Device Recalls (openFDA)
Abbott Laboratories HPD/ADD/GPRD: CA 125 Controls, list 9C22-10; Abbott Laboratories, Abbott Park, IL 60064
- Recall number
- Z-0322-04
- Recalling firm
- Abbott Laboratories HPD/ADD/GPRD
- Product
- CA 125 Controls, list 9C22-10; Abbott Laboratories, Abbott Park, IL 60064
- Status
- Terminated
- Initiated
- 2003-11-25
- Posted
- 2004-01-10
- Terminated
- 2004-07-26
- Reason
- The CA 125 assay product inserts list the incorrect storage instructions for the CA 125 Calibrators and Controls, and the product information letter (PI-P) shipped with the products to correct the storage conditions, 69-6349/R2, refers to an outdated control package insert, 39-1642/R3, instead of the current control package insert 34-1047/R4
- Root cause
- Other
- Action
- Field Correction recall by letter dated 11/25/03 to all customers receiving the affected reagents. The accounts were informed of the incorrect control package insert referenced in the product information letter shipped with each CA 125 product. The letters contained the correct control package insert number, 34-1047/R4, and stated that all CA 125 assay product inserts will be updated shortly to include the revised storage instructions for the CA 125 Calibrators and Controls.
- Quantity
- not on file
- Distribution
- Nationwide and internationally through Abbott subsidiaries in Argentina, Aruba, Australia, Bermuda, Brazil, Canada, Cayman Islands, Chile, Colombia, Ecuador, Germany, Peru, Hong Kong, India, Jamaica, Japan, Korea, New Zealand, Pakistan, Puerto Rico, Singapore, Taiwan, Thailand, United Kingdom and Uruguay.
- Lot, serial or model codes
- all lots
- 510(k) numbers
- ["K964185","K964929"]
- PMA numbers
- not on file
- Product code
- LTK--
- 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
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