FDA Medical Device Recalls (openFDA)
Innovacon Inc: Fisher Healthcare Sure-Vue Serum/Urine hCG-STAT; in vitro diagnostic test; Catalog Number: FHC-A202; Product Codes: FHC-A202-KFI3O & FHC-A202-KFI5O; Inverness Medical Professional Diagnostics, San Diego, CA 92121.
- Recall number
- Z-1118-2008
- Recalling firm
- Innovacon Inc
- Product
- Fisher Healthcare Sure-Vue Serum/Urine hCG-STAT; in vitro diagnostic test; Catalog Number: FHC-A202; Product Codes: FHC-A202-KFI3O & FHC-A202-KFI5O; Inverness Medical Professional Diagnostics, San Diego, CA 92121.
- Status
- Terminated
- Initiated
- 2007-10-01
- Posted
- 2008-05-06
- Terminated
- 2011-08-12
- Reason
- Incorrect results: The Sure-Vue Serum/Urine hCG-STAT test, when interpreted at extended read times, may exhibit sensitivity to patient samples containing hCG at levels well below the cut-off, potentially resulting in a false positive interpretation by the user.
- Root cause
- Labeling design
- Action
- Inverness Medical sent an Urgent Medical Device Alert letter, dated October 1, 2007, to all Innovacon customers for the product via US Postal Service return receipt requested. The field correction notice removed the extended read time of 10 minutes. Customers were instructed to note that although the package insert currently allows interpretation up to 10 minutes, do not read at times greater than 3 minutes for urine and 5 minutes for serum.
- Quantity
- 1,825,480 units
- Distribution
- Nationwide
- Lot, serial or model codes
- Lot Numbers: hCG6120203, hCG6120204, hCG7010080, hCG7010081, hCG7010038, hCG7010039, hCG7010040, hCG7030144, hCG7030145, hCG7030146, hCG7040076, hCG7040077, hCG7040078, hCG7040079, hCG7050121, hCG7050122, hCG7060073, hCG7060216, hCG7070042, hCG7070043, hCG7070044, hCG7007045, hCG7070060, hCG7070061, hCG7070186, hCG7070187, hCG7070191, hCG7080182, hCG7090049, hCG7090050, and hCG7090052.
- 510(k) numbers
- ["K062361"]
- PMA numbers
- not on file
- Product code
- JHI
- Firm FEI
- 3005689981
- Firm city
- San Diego
- Firm state
- CA
- 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