Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported March 11, 2020
PTS Detect Cotinine, Ref. No. 3061, UPC 381933061017 in vitro diagnostic - Product Usage: The PTS Detect cotinine system provides quantitative measurement of the nicotine metabolite cotinine (25 200 ng/mL) in capillary (fingerstick) or venous whole blood. The test is for professional use to determine if an individual has been exposed to nicotine.
The firm is removing the product from the market after discussions with the FDA due to lack of 510(k) clearance.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Polymer Technology Systems, Inc. recalled PTS Detect Cotinine, Ref. No. 3061, UPC 381933061017 in vitro diagnostic - Product Usage:… - a moderate-severity action.
PTS Detect Cotinine, Ref. No. 3061, UPC 381933061017 in vitro diagnostic - Product Usage:… was recalled by Polymer Technology Systems, Inc. in March 11, 2020. Reason: The firm is removing the product from the market after discussions with the FDA due to lack of 510(k) clearan…. Check the official notice for the remedy. Verify recall #Z-1438-2020 with the FDA Devices before acting.
The recall
Polymer Technology Systems, Inc. issued this moderate-severity FDA Devices recall-The firm is removing the product from the market after discussions with the FDA due to lack of 510(k) clearan….
- Moderate
- severity level
- 7K units
- affected scope
- Class II
- classification
- March 11, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1438-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1438-2020) was formally reported on March 11, 2020, with the manufacturer initiating the action on January 21, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. Polymer Technology Systems, Inc. is listed as the recalling firm, operating out of Indianapolis, IN. Federal records list the affected scope as 6790.
The documented reason for this recall is: The firm is removing the product from the market after discussions with the FDA due to lack of 510(k) clearance. Distribution data in the federal record shows the product reached: Domestic distribution nationwide. Foreign distribution to Belgium, South Africa, South Korea, and Poland.. 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
6790
Related Recalls
6
3 from same agency
Product description
PTS Detect Cotinine, Ref. No. 3061, UPC 381933061017 in vitro diagnostic - Product Usage: The PTS Detect cotinine system provides quantitative measurement of the nicotine metabolite cotinine (25 200 ng/mL) in capillary (fingerstick) or venous whole blood. The test is for professional use to determine if an individual has been exposed to nicotine.
Reason for recall
The firm is removing the product from the market after discussions with the FDA due to lack of 510(k) clearance.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1438-2020 |
| Date reported | March 11, 2020 |
| Date initiated | January 21, 2020 |
| Recalling firm | Polymer Technology Systems, Inc. |
| Firm location | Indianapolis, IN |
| Affected scope | 6790 |
| Distribution | Domestic distribution nationwide. Foreign distribution to Belgium, South Africa, South Korea, and Poland. |
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-1438-2020) 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? ▼
PTS Detect Cotinine, Ref. No. 3061, UPC 381933061017 in vitro diagnostic - Product Usage: The PTS Detect cotinine system provides quantitative measurement of the nicotine metabolite cotinine (25 200 ng/mL) in capillary (fingerstick) or venous whole blood. The test is for professional use to determine if an individual has been exposed to nicotine.. Recalled by Polymer Technology Systems, Inc.. Units affected: 6790.
Why was this product recalled? ▼
The firm is removing the product from the market after discussions with the FDA due to lack of 510(k) clearance.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 11, 2020. Severity: Moderate. Recall number: Z-1438-2020.
Where was the recalled product distributed? ▼
Distribution: Domestic distribution nationwide. Foreign distribution to Belgium, South Africa, South Korea, and Poland..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1438-2020) 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.
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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 March 11, 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.