Ortho-Clinical Diagnostics Recalls VITROS Chemistry Product Performance Verifier I
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Product Performance Verifier I units because multiple coatings of AMYL Slides show imprecision on control fluids.
What this means for you
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: The recall is classified as FDA Class II, but the source text describes a performance issue (imprecision) without reporting any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Product Performance Verifier I, Product Code 8231474, UDI # 10758750004577. This product is used for in vitro diagnostic purposes to quantitatively measure amylase activity in serum, plasma, and urine using specific VITROS Chemistry Systems and Integrated Systems.
The recall is due to multiple coatings of VITROS Chemistry Products AMYL Slides showing imprecision on control fluids when compared to the expected within lab standard deviation (SD) listed on the Performance Verifier (PV) Assay Sheets. The affected control assay sheets are identified as Current Control Assay Sheet SD 4.2, 4.3 and Revised Control Assay Sheet SD 6.8, 7.1.
The product was distributed worldwide, including nationwide in the United States across numerous states. Users of this product should contact Ortho-Clinical Diagnostics for further instructions on how to proceed with the recall.
The recalled product
- Product
- VITROS Chemistry Product Performance Verifier I, Product Code 8231474, UDI # 10758750004577 - Product Usage: For in vitro diagnostic use only to quantitatively measure amylase activity in serum, plasma, and urine using VITROS 250/350/5, 1 FS/4600/XT 3400 Chemistry Systems and VIT
- 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 (3)
- Current Control Assay Sheet SD 4.2
- 4.3 Revised Control Assay Sheet SD 6.8
- 7.1
Distribution
Part of a larger recall action
This product is one of 4 recalled by Ortho-Clinical Diagnostics under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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