Fisher Healthcare Sure-Vue Serum/Urine hCG-STAT; in vitro diagnostic test; Catalog Number: FHC-A202; Product Codes: FHC-
FDA device recall Z-1118-2008 · posted 2008-05-06 · Terminated
Recall details
- Recalling firm
- Innovacon Inc
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- JHI
- Quantity affected
- 1,825,480 units
- Distribution
- Nationwide
- Date initiated
- 2007-10-01
- Date posted
- 2008-05-06
- Date terminated
- 2011-08-12
- Location
- San Diego, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INNOVACON HCG UKTRA TEST DEVICE (K062361) | Innovacon, Inc. | 2006-10-23 |