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. The product is used for in vitro diagnostic testing.
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. The source text describes a performance issue (imprecision) but does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity recall involving potential risk of harm without reported adverse events.
Plain-English summary
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Product AMYL Slides Reagent, Product Code 1202670, UDI # 10758750008513. The recall involves 73,071 units of the product, which is used for in vitro diagnostic purposes to quantitatively measure amylase activity in serum, plasma, and urine. The affected lots are distributed worldwide, including nationwide in the United States.
The recall was initiated because multiple coatings of the VITROS Chemistry Products AMYL Slides are showing imprecision on control fluids when compared to the expected within lab standard deviation (SD) as listed on the Performance Verifier (PV) Assay Sheets. This issue may affect the accuracy of amylase measurements.
Healthcare facilities and laboratories should stop using the affected lots of VITROS AMYL Slides Reagent and contact Ortho-Clinical Diagnostics for instructions on returning or disposing of the product. The recall is classified as Class II by the FDA.
The recalled product
- Product
- VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/300 SLDS, Product Code 1202670, UDI # 10758750008513 - 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 C
- Manufacturer
- Ortho-Clinical Diagnostics
- Affected units
- 73,071
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 600203564949
- 600203564950
- 600203564975
- 600203564976
- 600203564977
- 600203564978
- 600203566275
- 600203566276
- 600203566277
- 600203566537
- 600203566538
- 600203566620
- 600203566621
- 600203566622
- 600203566698
- 600203566699
- 600203566700
- 600203567485
- 600203567486
- 600203567546
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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