Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported July 8, 2015
Cholesterol CHOD-PAP. In vitro diagnostic reagent system intended for use on the Hitachi systems for The quantitative determination of total cholesterol in serum and plasma.
Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of Trinder tests may be falsely decreased when the tests are run with urine…
Roche Diagnostics Operations, Inc. recalled Cholesterol CHOD-PAP. In vitro diagnostic reagent system intended for use on the Hitac… — a moderate-severity action.
Cholesterol CHOD-PAP. In vitro diagnostic reagent system intended for use on the Hitac… was recalled by Roche Diagnostics Operations, Inc. in July 8, 2015. Reason: Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of Tr…. Check the official notice for the remedy. Verify recall #Z-1920-2015 with the FDA Devices before acting.
The recall
Roche Diagnostics Operations, Inc. issued this moderate-severity FDA Devices recall — Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of Tr….
- Moderate
- severity level
- Class II
- classification
- July 8, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1920-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1920-2015) was formally reported on July 8, 2015, with the manufacturer initiating the action on May 7, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Roche Diagnostics Operations, Inc. is listed as the recalling firm, operating out of Indianapolis, IN. Federal records list the affected scope as 6,255 analytical units distributed.
The documented reason for this recall is: Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of Trinder tests may be falsely decreased when the tests are run with urine samples (Creatinine plus and Uric Acid… Distribution data in the federal record shows the product reached: US (nationwide) including PR.. 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, 6 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 — 40,409 medical devices recalls on record
Where this recall sits in the database
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 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
6,255 analytical units distributed
Related Recalls
6
6 from same agency
Product description
Cholesterol CHOD-PAP. In vitro diagnostic reagent system intended for use on the Hitachi systems for The quantitative determination of total cholesterol in serum and plasma.
Reason for recall
Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of Trinder tests may be falsely decreased when the tests are run with urine samples (Creatinine plus and Uric Acid applications only) or blood samples collected before sufficient time has lapsed after the administration of the drugs Acetaminophen and N-acetylcysteine.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1920-2015 |
| Date reported | July 8, 2015 |
| Date initiated | May 7, 2015 |
| Recalling firm | Roche Diagnostics Operations, Inc. |
| Firm location | Indianapolis, IN |
| Affected scope | 6,255 analytical units distributed |
| Distribution | US (nationwide) including PR. |
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-1920-2015) 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? ▼
Cholesterol CHOD-PAP. In vitro diagnostic reagent system intended for use on the Hitachi systems for The quantitative determination of total cholesterol in serum and plasma.. Recalled by Roche Diagnostics Operations, Inc.. Units affected: 6,255 analytical units distributed.
Why was this product recalled? ▼
Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of Trinder tests may be falsely decreased when the tests are run with urine samples (Creatinine plus and Uric Acid applications only) or blood samples collected before sufficient time has lapsed after the administration of the drugs Acetaminophen and N-acetylcysteine.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 8, 2015. Severity: Moderate. Recall number: Z-1920-2015.
Where was the recalled product distributed? ▼
Distribution: US (nationwide) including PR..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1920-2015) 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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Nearby Recalls in This Category
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported July 8, 2015.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records — no number is typed in by an editor. 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 June 2026.