FDA Medical Device Recalls (openFDA)
Abbott Laboratories HPD/ADD: Anti-HBs Reagent Kit, list 7C18-25, 100 tests; Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL 60064
- Recall number
- Z-0801-03
- Recalling firm
- Abbott Laboratories HPD/ADD
- Product
- Anti-HBs Reagent Kit, list 7C18-25, 100 tests; Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL 60064
- Status
- Terminated
- Initiated
- 2003-04-07
- Posted
- 2003-05-09
- Terminated
- 2003-08-19
- Reason
- Particulate matter in the microparticle component.
- Root cause
- Other
- Action
- Abbott affiliates in Canada, Germany and Japan were faxed copies of the recall letter on 4/7/03 for translation where needed and dissemination to their accounts receivin the suspect lot. The end users were advised of the mold-microparticle aggregation and instructed to discontinue use and destroy any of the lot remaining.
- Quantity
- 289 kits
- Distribution
- Canada, Germany and Japan
- Lot, serial or model codes
- List 7C18-25, lot 95305M200
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LOM--
- 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