CLASS II ONGOING Device recall · Reported 16 Aug 2023 · FDA Enforcement Report
Vitros Immunodiagnostic Products Troponin I ES Calibrators recalled
Ortho-clinical Diagnostics is recalling Vitros Immunodiagnostic Products Troponin I ES Calibrators, distributed nationwide in the US. The recall was initiated on 5 Jun 2023 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-2358-2023
- FDA event ID
- 92662
- Recalling firm
- Ortho-clinical Diagnostics, Bridgend, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 5 Jun 2023
- FDA classified
- 8 Aug 2023
- Reported
- 16 Aug 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 5 Jun 2023 | Recall initiated by company | |
| 8 Aug 2023 | Classified by FDA | +64 days |
| 16 Aug 2023 | 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
Reagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially false negative, results.
Product as listed by the FDA
VITROS Immunodiagnostic Products Troponin I ES Calibrators
Where it was distributed
Worldwide distribution - US Nationwide and the country of Canada.
Questions about this recall
Is Vitros Immunodiagnostic Products Troponin I ES Calibrators recalled?
Yes. Ortho-clinical Diagnostics recalled Vitros Immunodiagnostic Products Troponin I ES Calibrators on 5 Jun 2023. The recall is Class II and its status is Ongoing. Recall number Z-2358-2023.
Why was it recalled?
Reagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially false negative, results.
Which lots are affected?
Product Code: 6802302; UDI-DI: 10758750002511; Lot No.: 4800; Expiration Date: 10-Jun-2023.
Where was it sold?
Worldwide distribution - US Nationwide and the country of Canada.
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 Ortho-clinical Diagnostics
All 311| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Chemistry Products LAC Slides recalled by Ortho-Clinical Diagnostics | Ortho-Clinical Diagnostics | Device Malfunction | Nationwide |
| Device | CLASS II | Vitros Chemistry Products LAC Slides recalled | Ortho-Clinical Diagnostics | Device Malfunction | Nationwide |
| Device | CLASS II | Vitros Chemistry Products Ca Slides recalled | Ortho-Clinical Diagnostics | Device Malfunction | Nationwide |
| Device | CLASS II | Vitros Chemistry Products CHE Slides (Japan) recalled | Ortho-Clinical Diagnostics | Labeling Errors | Nationwide |
| Device | CLASS II | Vitros Chemistry Products CHE Slides recalled | Ortho-Clinical Diagnostics | Labeling Errors | Nationwide |
Other Test Kits & Diagnostics recalls
All 2,656| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | STA Staclot Protein S recalled by Diagnostica Stago | Diagnostica Stago | Potency & Assay | Nationwide |
| Device | CLASS II | DxC 500i Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |
| Device | CLASS II | DxC 500 AU Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |
| Device | CLASS II | Syva EMIT 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Beckman Coulter, Emit 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Lead & Heavy Metals | Nationwide |