Recall Z-0480-2009
Enterix, Inc. · initiated October 3, 2008
Product
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(R) Quik FIT(TM) Run Buffer, and 1 InSure(R) Quik FIT(TM) Product Instructions. Product 50025 - InSure(R) Quik FIT(TM) contains 25 Patient Kits & 1 Developer Kit.
Codes / lots: Lot number B1478, Exp. Date 11/30/2008
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.
FDA-determined cause: Other
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,
Details
- Recall number
- Z-0480-2009
- Initiated
- October 3, 2008
- Posted by FDA
- December 29, 2008
- Terminated
- March 26, 2009
- Product code
- KHE – Reagent, Occult Blood
- Quantity
- 45 kits (includes 25 patient collection kits and 1 developer kit)
- Distribution
- Product was distributed to medical facilities and laboratories throughout the US.
- Recalling firm
- Enterix, Inc., Edison, NJ