Z-0590-2021Class II

InSure ONE Test Strips (25 pack) vials-fecal immunochemical test (FIT) qualitatively detects human hemoglobin...

Name: Z-0590-2021 InSure ONE Test Strips (25 pack) vials-fecal immunochemical test (FIT) qualitatively detects human hemoglobin...
Creator: Enterix, Inc.
Published: 2020-10-08
License: https://open.fda.gov/license/

Enterix, Inc. / initiated 2020-10-08 / Terminated

FDA source

Enterix, Inc. began a recall of InSure ONE Test Strips (25 pack) vials-fecal immunochemical test (FIT) qualitatively detects human hemoglobin from blood in fecal samples Model 12045.01 on 2020-10-08. FDA classified it as Class II and gives the reason as "Product does not meet internal testing criterion; use of the product may result in a potential false positive test result and may lead to patients undergoing unnecessary follow-up diagnostic procedure, i.e., colonoscopy...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0590-2021
Classification: Class II
Status: Terminated
Initiated: 2020-10-08
Posted: 2020-12-15
Terminated: 2023-01-10
Recalling firm: Enterix, Inc.
Product: InSure ONE Test Strips (25 pack) vials-fecal immunochemical test (FIT) qualitatively detects human hemoglobin from blood in fecal samples Model 12045.01.
Product code: KHE Reagent, Occult Blood
Reason for recall: Product does not meet internal testing criterion; use of the product may result in a potential false positive test result and may lead to patients undergoing unnecessary follow-up diagnostic procedure, i.e., colonoscopy or sigmoidoscopy
FDA root cause: Under Investigation by firm
Action: Clinical Genomocs issued Recall Notice to customers starting 08OCT2020 via email. Letter states reason for recall, health risk and action to take: Immediately examine your inventory and quarantine product subject to this recall. In addition, if you have further distributed this product, please promptly identify and notify your customers of this product recall. You may use a copy of this recall notification to support the communication to your customers. This recall should be carried out to the user (laboratory) level. Your assistance is appreciated and necessary in order to prevent patients who may incur a false positive test result from undergoing an unnecessary follow-up diagnostic colonoscopy Actions to be taken by the Laboratory; " Inspect inventory and quarantine the following stock immediately; o InSure ONE Test Strip (25 pack) vials, Product Number 12045.01, Lot Numbers 770G11 and 770G21 " Complete the attached form Appendix 2: Recall Notice Acknowledgement and Receipt Form " Return the acknowledgement form asap (within 2 business days) via email; o Using the email subject line Test Strip Product Number 12045.01, Lot Numbers 770G11 and 770G21 o To [email protected] " Return the affected stock to the manufacturer; o Place in appropriate shipping carton and seal with shipping tape o Label box with RMA# (To be Provided by Clinical Genomics after Receipt of Acknowledgement Form) o Return via FED-Ex using Clinical Genomics Account # (To be Provided by Clinical Genomics after Receipt of Acknowledgment Form) o Attn: Operations Manager; 236 Fernwood Ave, Edison NJ 08837 Note the manufacturer has unaffected product in stock and replacement supply is available immediately. If you have any questions, please contact Customer Service, Clinical Genomics USA, + 1 732 429 1899
Quantity in commerce: US: 5,256 vials (131,400 test strips); OUS:1051 vials
Distribution: Worldwide distribution - US Nationwide and the country of Australia.
Product codes and lots: Lot Numbers: 770G11 and 770G21

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0590-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0590-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-23	2020-12-15

Product code KHE

K170548Class IIInSure ONEEnterix, Inc. / cleared 2017-10-05

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)