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.
FDA Recall Z-0480-2009 · Posted 2008-12-29
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Recalling FirmEnterix, Inc.
Recall StatusTerminated
Product CodeKHE
Date Initiated2008-10-03
Date Terminated2009-03-26
Product Quantity45 kits (includes 25 patient collection kits and 1 developer kit)
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.
Firm 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,
Root Cause
Other
Distribution Pattern
Product was distributed to medical facilities and laboratories throughout the US.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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