VITROS recallZ-1372-2024 · Ortho-Clinical Diagnostics · initiated Feb 27, 2024
Open, Classified
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 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
The issue was mismatched diluent lots assembled into VITRO Chemistry Products Performance Verifier I and II. This issue has the potential to cause erroneous Quality Control (QC) results that could lead to testing delays and erroneous patient results. This issue caused positive or negative bias in the quantification of sodium (Na+) and total carbon dioxide (ECO2). The incorrect diluent into the Performance Verifier II exhibited a potential negative bias of up to 6 mmol/L for ECO2 and Na+ testing.
FDA root cause category: Under Investigation by firm
What the company is doing
Consignees were sent an URGENT PRODUCT CORRECTION NOTIFICATION dated 2/27/24 informing them that for product Lot Q1174, diluent Lot M9815 was found in some sales units instead of the expected diluent Lot Q1175, and for product Lot R1176, diluent Lot P9967 was found in some sales units instead of the expected diluent Lot R1177. Consignees were asked to inspect their inventory to see if any mismatched product from affected lots was present and to discard any affected units. The provided Confirmation of Receipt form is to be returned by 3/8/24. Results received using affected devices are to be reviewed for any unexpected QC shift. The recall notification is to be forwarded if any devices were further distributed and the notification maintained in the User Documentation. Customers with any questions can call Global Services at 1-800-421-3311.
Recall details
- Recall number
- Z-1372-2024
- Status
- Open, Classified
- Initiated by the company
- Feb 27, 2024
- Posted by the FDA
- Mar 22, 2024
- Recalling firm
- Ortho-Clinical Diagnostics
- Quantity
- 10,911 units
- Product code
- JJY
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, United Kingdom.
Product description
VITROS Performance Verifier I
Code information (models, lots, serial numbers)
Product Code: 8067324; GTIN: 10758750004317; Lot No. Q1174.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- VITROS 8067324Ortho-Clinical Diagnostics, Inc. · Calibrator, secondary2 recalls0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 94174).
- Z-1373-2024 · Open, ClassifiedVITROS Performance Verifier II
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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