Ortho-Clinical Diagnostics Recalls VITROS AMYL Slides Reagent for Imprecision
Ortho-Clinical Diagnostics is recalling VITROS AMYL Slides Reagent because multiple coatings show imprecision on control fluids compared to expected standards.
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 does not report any hospitalizations, injuries, or illnesses. The hazard is a performance defect (imprecision) rather than a direct physical injury risk, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Product AMYL Slides Reagent, Product Code 8112724, UDI # 10758750004393. The recall involves 64,697 units distributed worldwide, including nationwide in the United States. The product is used for in vitro diagnostic purposes to quantitatively measure amylase activity in serum, plasma, and urine using specific VITROS Chemistry and Integrated Systems.
The recall was initiated because multiple coatings of the AMYL Slides are showing imprecision on control fluids when compared to the expected within-lab standard deviation listed on the Performance Verifier Assay Sheets. This issue affects the accuracy of the diagnostic results provided by the reagent.
Healthcare facilities and laboratories that have received these products should stop using the affected lots and contact Ortho-Clinical Diagnostics for further instructions. The specific lot numbers affected are listed in the structured product information provided by the agency.
The recalled product
- Product
- VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/90 SLDS, Product Code 8112724, UDI # 10758750004393 - 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 Chem
- Manufacturer
- Ortho-Clinical Diagnostics
- Affected units
- 64,697
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 (20)
- Lot #s 600203565250
- 600203565563
- 600203565573
- 600203565902
- 600203566266
- 600203566278
- 600203566676
- 600203567387
- 600203567388
- 600203567389
- 600303570323
- 600303570338
- 600303570824
- 600303570830
- 600303570847
- 600303570848
- 600303577945
- 600303578593
- 600303579040
- 600303579041
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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