VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges, of 18 slides per cartridge, for a total of 9
Summary
The FDA issued a Class II for VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges, of 1 by Ortho-Clinical Diagnostics, Inc.. Reason: Product was incorrectly assigned GEN 88 instead of GEN 83 on product carton, foil wrapper, and cartridge (cart) label..
Details
Source
Device Recall
External ID
Z-1876-2025
Action Date
2025-06-04
Status
Ongoing
Category
device
Product Description
VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges, of 18 slides per cartridge, for a total of 90 slides.
Lot/Code Info: 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.
Quantity Affected: 3,587 units
Reason for Recall
Product was incorrectly assigned GEN 88 instead of GEN 83 on product carton, foil wrapper, and cartridge (cart) label.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-04-14
Company
Rochester, NY
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 185 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Ortho-Clinical Diagnostics, Inc. has 71 FDA actions in our database, including 67 recalls and 4 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Ortho-Clinical Diagnostics, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Ortho-Clinical Diagnostics, Inc. have FDA actions?
Ortho-Clinical Diagnostics, Inc. has 71 FDA actions in our database, including 67 recalls and 4 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1876-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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