Ortho-Clinical Diagnostics Recalls VITROS Chemistry Products GLU Slides
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products GLU Slides due to potentially biased results.
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 3/5 (High).
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: The recall is classified as FDA Class II and involves a medical device that may produce biased results, posing a risk of harm through incorrect diagnosis or treatment, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products GLU Slides (Product Code: 1707801) because they may produce potentially biased results. The recall involves 329,700 slides distributed nationwide in the United States, specifically in Alabama, Arkansas, California, Colorado, Connecticut, Florida, Kansas, Kentucky, Massachusetts, Minnesota, and Tennessee.
The affected lot number is 0048-0964-9287, with an expiration date of November 1, 2020. These slides are used to quantitatively measure glucose concentration in serum, plasma, urine, and cerebrospinal fluid on various VITROS Chemistry Systems. The recall is classified as Class II by the FDA.
Healthcare facilities and laboratories should stop using the affected slides and contact Ortho-Clinical Diagnostics for further instructions on how to return or dispose of the product.
The recalled product
- Product
- VITROS Chemistry Products GLU Slides-Product Code:1707801. IVD VITROS Chemistry Products GLU Slides quantitatively measure glucose (GLU) concentration in serum, plasma, urine, and cerebrospinal fluid using VITROS 250/350/5,1 FS/4600 Chemistry Systems and VITROS 5600/XT 7600…
- Manufacturer
- Ortho-Clinical Diagnostics
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 (2)
- Lot Number:0048-0964-9287
- Exp Date:2020-11-01 UDI: 10758750009572
Distribution
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