VITROS Immunodiagnostic Products Troponin I ES Reagent Pack recallZ-2357-2023 · Ortho-Clinical Diagnostics · initiated Jun 5, 2023
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
Reagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially false negative, results.
FDA root cause category: Process control
What the company is doing
Customers were sent a recall notification by mail dated 06/05/2023. The notification that customers immediately discontinue use of affected devices and discard any remaining inventory. Any discarded product will be replaced by QuidelOrtho or credit will be provided. Customers are asked to return the provided Confirmation of Receipt Form no later than 06/12/2023. If affected devices were further distributed customers are asked to forward the provided notification to those downstream customers. This notice is to be posted by all VITROS Systems until the expiration of affected devices, which is 06/10/2023. Customers with any questions may contact Quidel Ortho at 1-800-421-3311.
Recall details
- Recall number
- Z-2357-2023
- Status
- Open, Classified
- Initiated by the company
- Jun 5, 2023
- Posted by the FDA
- Aug 8, 2023
- Recalling firm
- Ortho-Clinical Diagnostics
- Quantity
- 4,013 units
- Product code
- MMI
- FDA submissions
- K062838, K992366
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
Product description
VITROS Immunodiagnostic Products Troponin I ES Reagent Pack
Code information (models, lots, serial numbers)
Product Code: 6802301; UDI-DI: 10758750002504; Lot No.: 4800; Expiration Date: 10-Jun-2023.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- VITROS 6802301Ortho Clinical Diagnostics · IMMUNOASSAY METHOD, TROPONIN SUBUNIT1 recall139 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 92662).
- Z-2358-2023 · Open, ClassifiedVITROS Immunodiagnostic Products Troponin I ES Calibrators
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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