CLASS II Device recall · Reported 23 Dec 2020 · FDA Enforcement Report
InSure ONE Test Strips vials-fecal immunochemical test recalled
Enterix is recalling InSure ONE Test Strips vials-fecal immunochemical test (FIT) qualitatively detects human, distributed nationwide in the US. The recall was initiated on 8 Oct 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0590-2021
- FDA event ID
- 86674
- Recalling firm
- Enterix, Edison, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Oct 2020
- FDA classified
- 15 Dec 2020
- Reported
- 23 Dec 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Lead & Heavy Metals
- Device type
- Insulin Pumps & Glucose Monitors
Timeline
| 8 Oct 2020 | Recall initiated by company | |
| 15 Dec 2020 | Classified by FDA | +68 days |
| 23 Dec 2020 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
InSure ONE Test Strips (25 pack) vials-fecal immunochemical test (FIT) qualitatively detects human hemoglobin from blood in fecal samples Model 12045.01.
Where it was distributed
Worldwide distribution - US Nationwide and the country of Australia.
Questions about this recall
Is InSure ONE Test Strips vials-fecal immunochemical test (FIT) qualitatively detects human recalled?
Yes. Enterix recalled InSure ONE Test Strips vials-fecal immunochemical test (FIT) qualitatively detects human on 8 Oct 2020. The recall is Class II and its status is Terminated. Recall number Z-0590-2021.
Why was it recalled?
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
Which lots are affected?
Lot Numbers: 770G11 and 770G21
Where was it sold?
Worldwide distribution - US Nationwide and the country of Australia.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Enterix
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | InSure ONE Fecal Immunochemical Test recalled by Enterix | Enterix | Other | Nationwide |
Other Insulin Pumps & Glucose Monitors recalls
All 459| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Other | Nationwide |
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Other | Nationwide |
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Other | Nationwide |
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Lead & Heavy Metals | Nationwide |
| Device | CLASS I | Omnipod (Eros) Pod recalled by Insulet | Insulet | Lead & Heavy Metals | Nationwide |