[pending] VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges, of 18 slides per cartrid
Pending LLM rewrite. Source: FDA_DEVICE Z-1876-2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Product was incorrectly assigned GEN 88 instead of GEN 83 on product carton, foil wrapper, and cartridge (cart) label.
The recalled product
- Product
- VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges, of 18 slides per cartridge, for a total of 90 slides.
- Manufacturer
- Ortho-Clinical Diagnostics, Inc.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- 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.
Distribution
Distributed nationwide across the United States.
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