FDA Medical Device Recalls (openFDA)
Abbott Laboratories HPD/ADD/GPRD: IMx Rubella IgM Reagent Kit, 100 tests, list 7A24-20; Abbott Laboratories, Abbott Park, IL 60064
- Recall number
- Z-1129-03
- Recalling firm
- Abbott Laboratories HPD/ADD/GPRD
- Product
- IMx Rubella IgM Reagent Kit, 100 tests, list 7A24-20; Abbott Laboratories, Abbott Park, IL 60064
- Status
- Terminated
- Initiated
- 2003-07-22
- Posted
- 2003-08-13
- Terminated
- 2003-09-16
- Reason
- The package insert contains incomplete information for the English text. Pages 4 and 5 are missing and pages 14 and 15 are duplicated.
- Root cause
- Other
- Action
- Recall letters dated 7/21/03 were sent to the accounts by Federal Express Priority on 7/22/03, informing the accounts of the error in the package insert and instructing them to discontinue using the incorrect insert (commodity 34-0284/R8) and used the enclosed revised insert (commodity 34-2915/R9) with lot 01687M300. The revised package insert 34-2915/R9 was inadvertently omitted from the first mailing and was sent on 7/23/03.
- Quantity
- 423 kits
- Distribution
- California, Michigan, North Carolina, Ohio, Tennessee, Wisconsin, Georgia, Illinois, Kentucky, Massachusetts and Texas, and internationally to Columbia, Peru, Uruguay, Brazil, San Salvador, Canada, Germany, Singapore, Korea and Honduras
- Lot, serial or model codes
- list 7A24-20, lot 01687M300
- 510(k) numbers
- K931059
- PMA numbers
- not on file
- Product code
- LFX
- 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
- 2026-10-14
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