VITROS recallZ-1876-2025 · Ortho-Clinical Diagnostics, Inc. · initiated Apr 14, 2025
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, 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
Product was incorrectly assigned GEN 88 instead of GEN 83 on product carton, foil wrapper, and cartridge (cart) label.
FDA root cause category: Process control
What the company is doing
An URGENT PRODUCT CORRECTION NOTIFICATION was mailed to consignees. The notification to distributors instructs consignees to forward the provided notification and Customer Confirmation Receipt to all customers who were shipped affected lots and to discontinue distributing affected lots. Affected lots in possession of distributors should be discarded. Distributors are asked to return a completed Distributor Confirmation Receipt form. The notification to customers instructs consignees to check their inventory and destroy any identified product subject to this recall. Consignees are instructed to post the provided notification near all VITROS devices and within device User Documentation until the issue has been resolved. A copy of the recall notification should be forwarded if a unit was distributed outside your facility. Consignees are to complete and return the provided Confirmation of Receipt form.
Recall details
- Recall number
- Z-1876-2025
- Status
- Open, Classified
- Initiated by the company
- Apr 14, 2025
- Posted by the FDA
- May 29, 2025
- Recalling firm
- Ortho-Clinical Diagnostics, Inc.
- Quantity
- 3,587 units
- Product code
- DCK
- FDA submissions
- K953197, K152433
- Distribution
- Worldwide - US Nationwide distribution in the states of AR, AZ, CO, FL, GA, ID, IL, IN, KS, MI, MN, MO, MS, MT, ND, NE, NH, NJ, NY, OH, OK, PA, SC, TN, TX, VA, WI, WV & WY and the countries of Canada, Chile, Colombia, France, India, Italy, Mexico & Singapore.
Product description
VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges, of 18 slides per cartridge, for a total of 90 slides.
Code information (models, lots, serial numbers)
Catalog number: 8097990; GTIN#: 10758750004355; Coating Number: 1291; Lot No. 3788-1291-0019, 3788-1291-0052, 3788-1291-0078, 3788-1291-0079, 3788-1291-0080, 3788-1291-9975.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- VITROS 8097990Ortho-Clinical Diagnostics, Inc. · C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL1 recall1 report
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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