INSURE(R) QUIK FIT(TM) DEVELOPER KIT, Lot number B1478, Product Numbers: 30025 (InSure Quik FIT Developer Kit) and 50025
FDA device recall Z-0480-2009 · posted 2008-12-29 · Terminated
Recall details
- Recalling firm
- Enterix, Inc.
- Reason for recall
- False readings: Reduced sensitivity could affect the test line area and/or control line on the test strips, which may lead to inaccurate results. For further information, please contact Enterix, Inc. at 1-800-531--3681.
- Action taken
- Medical Device Recall Letters were sent on October 3, 2008 to all customers by certified mail. The letters were entitled "URGENT *** MEDICAL DEVICE RECALL (U.S. ONLY). Questions are to be directed to Enterix at 1-800-531-3681,
- Root cause
- Other
- Status
- Terminated
- Product code
- KHE
- Quantity affected
- 45 kits (includes 25 patient collection kits and 1 developer kit)
- Distribution
- Product was distributed to medical facilities and laboratories throughout the US.
- Date initiated
- 2008-10-03
- Date posted
- 2008-12-29
- Date terminated
- 2009-03-26
- Location
- Edison, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INSURE II (K060930) | Enterix, Inc. | 2006-05-04 |