InSure ONE Test Strips (25 pack) vials-fecal immunochemical test (FIT) qualitatively detects human hemoglobin from blood in fecal samples Model 12045.01.
FDA Recall Z-0590-2021 · Posted None
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Recalling FirmEnterix, Inc.
Recall StatusTerminated
Product CodeKHE
Date Initiated2020-10-08
Date Terminated2023-01-10
Product QuantityUS: 5,256 vials (131,400 test strips); OUS:1051 vials
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
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
Root Cause
Under Investigation by firm
Distribution Pattern
Worldwide distribution - US Nationwide and the country of Australia.
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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