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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Innovacon Inc
Lot Codes / Batch Numbers
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.
Products Sold
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.
Innovacon Inc is recalling Fisher Healthcare Sure-Vue Serum/Urine hCG-STAT; in vitro diagnostic test; Catalog Number: FHC-A202; due to Incorrect results: The Sure-Vue Serum/Urine hCG-STAT test, when interpreted at extended read times, may exhibit sensitivity to patient samples contain. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026