CLASS II Device recall · Reported 8 Jul 2015 · FDA Enforcement Report
Cholesterol Chod-pap recalled by Roche Diagnostics Operations
Roche Diagnostics Operations is recalling Cholesterol Chod-pap, distributed nationwide in the US. The recall was initiated on 7 May 2015 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-1920-2015
- FDA event ID
- 71182
- Recalling firm
- Roche Diagnostics Operations, Indianapolis, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 May 2015
- FDA classified
- 27 Jun 2015
- Reported
- 8 Jul 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 7 May 2015 | Recall initiated by company | |
| 27 Jun 2015 | Classified by FDA | +51 days |
| 8 Jul 2015 | Published in enforcement report | +11 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
US (nationwide) including PR.
Questions about this recall
Is Cholesterol Chod-pap recalled?
Yes. Roche Diagnostics Operations recalled Cholesterol Chod-pap on 7 May 2015. The recall is Class II and its status is Terminated. Recall number Z-1920-2015.
Why was it 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 lots are affected?
Catalog Numbers: 11491458216; 11875540216; 11875523216.
Where was it sold?
US (nationwide) including PR.
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.
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