Recall Z-0480-2009 ยท KHE Reagent, Occult Blood
Enterix, Inc.
INSURE(R) QUIK FIT(TM) DEVELOPER KIT, Lot number B1478, Product Numbers: 30025 (InSure Quik FIT Developer Kit) and 50025 (INSURE(R) QUIK FIT(TM) containing Developer Kit and Patient Collection Kits. Product Number 30025 - InSure(R) Quik FIT)TM) Developer Kit (1 Box) . Each box contains: 25 InSure(R) Quik FIT(TM) Test Strips (1 per foil pack), 1 InSure(R) Quik FIT(TM) Conjugate Solution, I InSure
| Date | Dec 29, 2008 (initiated Oct 3, 2008) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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, |
| Quantity | 45 kits (includes 25 patient collection kits and 1 developer kit) |
| Distribution | Product was distributed to medical facilities and laboratories throughout the US. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060930 | INSURE II Enterix, Inc., May 4, 2006 |