FDA Medical Device Recalls (openFDA)
Enterix, Inc.: InSure ONE Test Strips (25 pack) vials-fecal immunochemical test (FIT) qualitatively detects human hemoglobin from blood in fecal samples Model 12045.01.
- Recall number
- Z-0590-2021
- 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.
- Status
- Terminated
- Initiated
- 2020-10-08
- Posted
- not on file
- Terminated
- 2023-01-10
- Reason
- 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
- 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 regulatory@clinicalgenomics.com " 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
- US: 5,256 vials (131,400 test strips); OUS:1051 vials
- Distribution
- Worldwide distribution - US Nationwide and the country of Australia.
- Lot, serial or model codes
- Lot Numbers: 770G11 and 770G21
- 510(k) numbers
- ["K170548"]
- PMA numbers
- not on file
- Product code
- KHE
- Firm FEI
- 3003224146
- Firm city
- Edison
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28