Ortho-Clinical Diagnostics Recalls VITROS TRIG Slides Due to Biased Results
Ortho-Clinical Diagnostics is recalling specific VITROS TRIG slides due to a potential for biased test results. The recall affects 380 units in the US and 155 units internationally.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when the defect involves significant diagnostic accuracy issues that could impact patient care.
Plain-English summary
Ortho-Clinical Diagnostics is recalling VITROS CHEMISTRY PRODUCTS TRIG Slides, Reference 133 6544, due to a potential for biased results. The affected product is an in vitro diagnostic (IVD) used to quantitatively measure triglyceride concentration in serum and plasma. The recall is limited to Lot 0704-3318-4774, which has an expiry date of December 1, 2015.
The recall involves 380 units distributed in the United States and 155 units distributed internationally. The products were distributed nationwide in the US, as well as to Puerto Rico and various countries including Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela.
The FDA has classified this recall as Class II. Users of the affected slides should stop using them and contact the manufacturer for further instructions.
The recalled product
- Product
- VITROS CHEMISTRY PRODUCTS TRIG Slides, REF 133 6544, IVD For in vitro diagnostic use only. VITROS Chemistry Products TRIG Slides quantitatively measure triglyceride (TRIG) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the…
- Manufacturer
- Ortho-Clinical Diagnostics
- Hazard
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 0704-3318-4774 (expiry date 01 Dec 2015)
Distribution
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