VITROS recallZ-1688-2021 · Ortho-Clinical Diagnostics, INc. · initiated May 3, 2021
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Ortho-Clinical Diagnostics, INc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Ortho investigated and confirmed the potential for unexpected failed calibration, and condition codes associated with the calibration, when using VITROS SARS-CoV-2 Ag Reagent Pack along with VITROS Immunodiagnostic Products SARS-CoV-2 Ag Calibrator, Lot 20.
FDA root cause category: Under Investigation by firm
What the company is doing
On May 4, 2021, Ortho Clinical Diagnostics issued an Urgent Medical Device Correction notice to customers via letter notifying them of calibration failures and the associated condition code for specified calibrator lots. Customers received the following instructions. " Discontinue using VITROS SARS-CoV-2 Antigen Reagent/Calibrator Lot 0064, discard any remaining inventory and switch to an alternate lot. " Ortho will credit and/or replace all remaining inventory of VITROS SARS-CoV-2 Antigen Reagent/Calibrator Lot 0064 as indicated on the Confirmation of Receipt form. " Complete the enclosed Confirmation of Receipt form no later than MM/DD/YY, even if your facility no longer has the affected product in inventory. " Please forward this notification if the product was distributed outside of your facility.
Recall details
- Recall number
- Z-1688-2021
- Status
- Terminated
- Initiated by the company
- May 3, 2021
- Recalling firm
- Ortho-Clinical Diagnostics, INc.
- Quantity
- 74 units
- Product code
- QKP
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AR, CA, IA, IL, LA, MO, MS, TX, WI, and the countries of Colombia, India, Japan, Italy, Spain, Portugal, France.
Product description
VITROS CoV2 Ag calibrator (Product Code 6199950) - Product Usage: is a chemiluminescent immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in nasopharyngeal (NP) and anterior nasal swab specimens collected in CDCs formulation of VTM.
Code information (models, lots, serial numbers)
Unique Identifier: 10758750033591 Lot: 0020
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- VITROS 6199950Ortho-Clinical Diagnostics, Inc. · Coronavirus antigen detection test system.1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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