CLASS II ONGOING Device recall · Reported 10 Oct 2018 · FDA Enforcement Report
Vitros Immunodiagnostic Products recalled by Ortho Clinical Diagnostics
Ortho Clinical Diagnostics is recalling Vitros Immunodiagnostic Products - Folate Reagent Pack(10758750009237) 1513266, distributed nationwide in the US. The recall was initiated on 12 Jul 2018 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-0058-2019
- FDA event ID
- 80717
- Recalling firm
- Ortho Clinical Diagnostics, Raritan, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 12 Jul 2018
- FDA classified
- 3 Oct 2018
- Reported
- 10 Oct 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 12 Jul 2018 | Recall initiated by company | |
| 3 Oct 2018 | Classified by FDA | +83 days |
| 10 Oct 2018 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The recalling firm determined that biased results may occur for specific VITROS Immunodiagnostic Products (MicroWell Assays) at biotin concentrations which are lower than indicated in the current Instructions For Use (IFU). Patients who are taking biotin supplements could potentially have biased sample results for affected assays at biotin concentrations lower than indicated in the current IFU.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
VITROS Immunodiagnostic Products - Folate Reagent Pack(10758750009237) 1513266
Where it was distributed
Worldwide Distribution - US Nationwide distribution, and countries of Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Singapore, United Kingdom, France, Germany, Italy, Spain, Portugal, Poland, Russia, Denmark, Norway, Sweden, Belgium, and Netherlands.
Questions about this recall
Why was it recalled?
The recalling firm determined that biased results may occur for specific VITROS Immunodiagnostic Products (MicroWell Assays) at biotin concentrations which are lower than indicated in the current Instructions For Use (IFU). Patients who are taking biotin supplements could potentially have biased sample results for affected assays at biotin concentrations lower than indicated in the current IFU.
Which lots are affected?
2470 2480 2490 2501 2510 2521
Where was it sold?
Worldwide Distribution - US Nationwide distribution, and countries of Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Singapore, United Kingdom, France, Germany, Italy, Spain, Portugal, Poland, Russia, Denmark, Norway, Sweden, Belgium, and Netherlands.
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 80717| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Vitros Immunodiagnostic Products - FSH Reagent Pack recalled | Ortho Clinical Diagnostics | Potency & Assay | Nationwide | |
| CLASS II | Vitros Immunodiagnostic Products - Prolactin Reagent Pack recalled | Ortho Clinical Diagnostics | Potency & Assay | Nationwide | |
| CLASS II | Vitros Immunodiagnostic Products - TSH Reagent Pack recalled | Ortho Clinical Diagnostics | Potency & Assay | Nationwide |
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 |
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