| Date Initiated by Firm |
October 08, 2020 |
| Create Date |
December 15, 2020 |
| Recall Status1 |
Terminated 3 on January 10, 2023 |
| Recall Number |
Z-0590-2021 |
| Recall Event ID |
86674 |
| 510(K)Number |
K170548
|
| Product Classification |
Reagent, occult blood - Product Code KHE
|
| Product |
InSure ONE Test Strips (25 pack) vials-fecal immunochemical test (FIT) qualitatively detects human hemoglobin from blood in fecal samples Model 12045.01. |
| Code Information |
Lot Numbers: 770G11 and 770G21 |
Recalling Firm/
Manufacturer |
Enterix, Inc.
236 Fernwood Ave
Edison NJ 08837-3839
|
| For Additional Information Contact |
Client Experience Staff
732-429-1899
|
Manufacturer 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 Determined
Cause 2 |
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 in Commerce |
US: 5,256 vials (131,400 test strips); OUS:1051 vials |
| Distribution |
Worldwide distribution - US Nationwide and the country of Australia. |
| 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.
|
