Recall Z-1118-2008 ยท JHI Visual, Pregnancy Hcg, Prescription Use
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.
| Date | May 6, 2008 (initiated Oct 1, 2007) |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062361 | INNOVACON HCG UKTRA TEST DEVICE Innovacon, Inc., Oct 23, 2006 |