Ortho-Clinical Diagnostics Recalls VITROS Chemistry Products Na+ Slides
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products Na+ Slides because imprecision in the affected lot may produce biased patient sample and quality control fluid results.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, which corresponds to a severity score of 4 (Severe) per the rubric, as it involves a reasonable probability of temporary or medically reversible adverse health consequences.
Plain-English summary
Ortho-Clinical Diagnostics is recalling 1,448 units of VITROS Chemistry Products Na+ Slides, Catalog Number 8379034, Lot 4221-0998-3223. These products are used for in vitro diagnostic purposes to quantitatively measure sodium (Na+) concentration in serum, plasma, and urine using specific VITROS Chemistry Systems.
The recall was initiated because imprecision in the affected lot may produce negatively or positively biased patient sample and quality control fluid results. The agency has classified this recall as Class II.
The affected units were distributed in the United States to the states of AL, CA, CT, FL, HI, IA, ID, IL, LA, MI, MO, MS, NC, NM, NY, OK, PA, TX, WV, and WY, as well as internationally to Canada. Healthcare facilities and laboratories should stop using the affected lots and contact the recalling firm for further instructions.
The recalled product
- Product
- VITROS Chemistry Products Na+ Slides, Catalog Number 8379034 For in vitro diagnostic use only. VITROS Na+ Slides quantitatively measure sodium (Na+) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integra
- Manufacturer
- Ortho-Clinical Diagnostics
- Affected units
- 1,448
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 (1)
- Lot 4221-0998-3223
Distribution
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