CLASS II ONGOING Device recall · Reported 26 Apr 2023 · FDA Enforcement Report
Vitros Immunodiagnostic Products Anti-SARSCoV- 2 Total N recalled
Ortho-Clinical Diagnostics is recalling Vitros Immunodiagnostic Products Anti-SARSCoV- 2 Total N Antibody Calibrators programmed, distributed nationwide in the US. The recall was initiated on 9 Mar 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-1396-2023
- FDA event ID
- 92017
- Recalling firm
- Ortho-Clinical Diagnostics, Raritan, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 9 Mar 2023
- FDA classified
- 18 Apr 2023
- Reported
- 26 Apr 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 9 Mar 2023 | Recall initiated by company | |
| 18 Apr 2023 | Classified by FDA | +40 days |
| 26 Apr 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
Incorrect Number of Calibrator Levels (2) Set for the VITROS Immunodiagnostics Products Anti-SARS-CoV-2 Total N Antibody Calibrators in Assay Data Disks (ADD), resulting in delayed patients results
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 Anti-SARSCoV- 2 Total N Antibody Calibrators programmed onto the Assay Data Disks (ADD) Data Release Versions (DRV): DRVs 6213 through 6218 supporting VITROS Calibrators. Product Code: 6199976
Where it was distributed
US Nationwide distribution in the states of AL, AZ, CA, GA, NY.
Questions about this recall
Why was it recalled?
Incorrect Number of Calibrator Levels (2) Set for the VITROS Immunodiagnostics Products Anti-SARS-CoV-2 Total N Antibody Calibrators in Assay Data Disks (ADD), resulting in delayed patients results
Which lots are affected?
UDI: 10758750034581 Lot # /Expiration Date: 0230 22-Feb-2023; 0240 22-Mar-2023; 0250 26-Apr-2023.
Where was it sold?
US Nationwide distribution in the states of AL, AZ, CA, GA, NY.
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.
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