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U.S. Department of Health and Human Services

Class 2 Device Recall InSure(R) Quik FIT(TM)

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  Class 2 Device Recall InSure(R) Quik FIT(TM) see related information
Date Initiated by Firm October 03, 2008
Date Posted December 29, 2008
Recall Status1 Terminated 3 on March 26, 2009
Recall Number Z-0480-2009
Recall Event ID 49560
510(K)Number K060930  
Product Classification Occult Blood Test - Product Code KHE
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.
Code Information Lot number B1478, Exp. Date 11/30/2008 
Recalling Firm/
Manufacturer		 Enterix, Inc.
236 Fernwood Ave
Edison NJ 08837-3839
For Additional Information Contact Edwin Diaz
732-429-1899
Manufacturer 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 2		 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 in Commerce 45 kits (includes 25 patient collection kits and 1 developer kit)
Distribution Product was distributed to medical facilities and laboratories throughout the US.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KHE and Original Applicant = ENTERIX INC.
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