VITROS Chemistry Products CRP Slides Incorrectly Labeled Coating Generation
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products CRP Slides because the product carton, foil wrapper, and cartridge label were incorrectly marked with "GEN 88" instead of the correct "GEN 83" designation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving a labeling error on a medical device. The source text indicates only a generation designation mislabel with no reported patient harm or safety impact described, making it a moderate-severity labeling discrepancy rather than a higher-tier safety hazard.
Plain-English summary
Ortho-Clinical Diagnostics, Inc. is recalling VITROS Chemistry Products CRP Slides due to incorrect labeling of the product generation designation. The product carton, foil wrapper, and cartridge label were assigned "GEN 88" instead of the correct "GEN 83."
Approximately 3,587 units have been distributed worldwide, including US distribution across 30 states (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, and WY) and eight countries (Canada, Chile, Colombia, France, India, Italy, Mexico, and Singapore). The affected product can be identified by Catalog Number 8097990, GTIN#10758750004355, Coating Number 1291, and the following lot numbers: 3788-1291-0019, 3788-1291-0052, 3788-1291-0078, 3788-1291-0079, 3788-1291-0080, and 3788-1291-9975.
Customers and healthcare providers who have received this product should contact Ortho-Clinical Diagnostics, Inc. regarding the mislabeling and potential corrective actions.
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.
- Hazard
- Affected units
- 3,587
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
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