Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported December 23, 2020
InSure ONE Test Strips (25 pack) vials-fecal immunochemical test (FIT) qualitatively detects human hemoglobin from blood in fecal samples Model 12045.01.
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…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Enterix, Inc. recalled InSure ONE Test Strips (25 pack) vials-fecal immunochemical test (FIT) qualitatively det… - a moderate-severity action.
InSure ONE Test Strips (25 pack) vials-fecal immunochemical test (FIT) qualitatively det… was recalled by Enterix, Inc. in December 23, 2020. Reason: Product does not meet internal testing criterion; use of the product may result in a potential false positive…. Check the official notice for the remedy. Verify recall #Z-0590-2021 with the FDA Devices before acting.
The recall
Enterix, Inc. issued this moderate-severity FDA Devices recall-Product does not meet internal testing criterion; use of the product may result in a potential false positive….
- Moderate
- severity level
- Class II
- classification
- December 23, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0590-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0590-2021) was formally reported on December 23, 2020, with the manufacturer initiating the action on October 8, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. Enterix, Inc. is listed as the recalling firm, operating out of Edison, NJ. Federal records list the affected scope as US: 5,256 vials (131,400 test strips); OUS:1051 vials.
The documented reason for this recall is: 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… Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide and the country of Australia.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
US: 5,256 vials (131,400 test strips); OUS:1051 vials
Related Recalls
6
3 from same agency
Product description
InSure ONE Test Strips (25 pack) vials-fecal immunochemical test (FIT) qualitatively detects human hemoglobin from blood in fecal samples Model 12045.01.
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
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0590-2021 |
| Date reported | December 23, 2020 |
| Date initiated | October 8, 2020 |
| Recalling firm | Enterix, Inc. |
| Firm location | Edison, NJ |
| Affected scope | US: 5,256 vials (131,400 test strips); OUS:1051 vials |
| Distribution | Worldwide distribution - US Nationwide and the country of Australia. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0590-2021) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
InSure ONE Test Strips (25 pack) vials-fecal immunochemical test (FIT) qualitatively detects human hemoglobin from blood in fecal samples Model 12045.01.. Recalled by Enterix, Inc.. Units affected: US: 5,256 vials (131,400 test strips); OUS:1051 vials.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on December 23, 2020. Severity: Moderate. Recall number: Z-0590-2021.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution - US Nationwide and the country of Australia..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0590-2021) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
CPSC Moderate
Rowenta Recalls Cordless Vacuum Cleaners Due to Risk of Serious Injury from Fire and Burn Hazards
· 2026-07-02
CPSC Moderate
Daikin Comfort Technologies Manufacturing Recalls Amana Air Conditioners and Heat Pumps Due to Risk of Serious Injury f…
· 2026-06-25
CPSC Moderate
Arizer Solo III Portable Vaporizers Recalled Due to Fire and Burn Hazards; Risk of Serious Injury or Death; Imported by…
· 2026-06-18
FDA Devices Moderate
GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603-902, Product Code KSA; used i…
GE Medical Systems Information Technologies Inc · 2026-06-03
FDA Devices Critical
Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) BLOCK TRAY, Medline Kit…
Medline Industries, LP · 2026-06-03
Compare this recall with Rowenta Recalls Cordless Vacuum Cleaners Due to Risk of Ser… →
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported December 23, 2020. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.