FDA Medical Device Recalls (openFDA)
Abbott Laboratories MPG: ABBOTT TestPack +Plus hCG Combo with On Board Controls (OBC), list number 7B34-16; the kit contains 20 reaction discs, Anti-beta hCG (Goat) and Anti-alpha hCG (Mouse, Monoclonal) coated; Abbott Laboratories, Abbott Park, IL 60064 USA
- Recall number
- Z-1392-05
- Recalling firm
- Abbott Laboratories MPG
- Product
- ABBOTT TestPack +Plus hCG Combo with On Board Controls (OBC), list number 7B34-16; the kit contains 20 reaction discs, Anti-beta hCG (Goat) and Anti-alpha hCG (Mouse, Monoclonal) coated; Abbott Laboratories, Abbott Park, IL 60064 USA
- Status
- Terminated
- Initiated
- 2005-03-16
- Posted
- 2005-08-24
- Terminated
- 2006-05-25
- Reason
- False Positive results may be obtained with the identified lots of list 7B34-16 when using a negative patient sample or a negative control.
- Root cause
- Other
- Action
- Abbott notified their affiliates in all four countries via e-mail on 3/16/05. Each Abbott international country organization is responsible for translating the customer letter, contacting customers and determining the method of effectiveness checks based on their country requirements. The recall letters inform the accounts of the false positve results, and were requested to destroy any remaining inventory of the affected lots.
- Quantity
- 7607 kits
- Distribution
- Canada, Germany, Hong Kong and Australia
- Lot, serial or model codes
- list number 7B34-16, lot numbers 16006M200 and 19199M300
- 510(k) numbers
- ["K965116"]
- PMA numbers
- not on file
- Product code
- JHI
- 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