Z-0480-2009

INSURE(R) QUIK FIT(TM) DEVELOPER KIT, Lot number B1478, Product Numbers: 30025 (InSure Quik FIT Developer...

Name: Z-0480-2009 INSURE(R) QUIK FIT(TM) DEVELOPER KIT, Lot number B1478, Product Numbers: 30025 (InSure Quik FIT Developer...
Creator: Enterix, Inc.
Published: 2008-10-03
License: https://open.fda.gov/license/

Enterix, Inc. / initiated 2008-10-03 / Terminated

FDA source

Enterix, Inc. began a recall of 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... on 2008-10-03. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0480-2009
Status: Terminated
Initiated: 2008-10-03
Posted: 2008-12-29
Terminated: 2009-03-26
Recalling firm: Enterix, Inc.
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.
Product code: KHE Reagent, Occult Blood
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 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 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.
Product codes and lots: Lot number B1478, Exp. Date 11/30/2008

Product code KHE

K060930Class IIInsure IIEnterix, Inc. / cleared 2006-05-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)