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 Chemistry Systems and V
Check against the official notice below — it lists the full affected range.
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Product AMYL Slides Reagent (Product Code 1202670) because multiple coatings of the product are showing imprecision when tested on control fluids compared to the expected precision levels listed on the Performance Verifier Assay Sheets. The affected product was distributed worldwide and throughout the United States, with approximately 73,071 units recalled across 73 specific lot numbers.
The recall affects clinical laboratories using this in vitro diagnostic reagent for amylase testing. The source document does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fluids when compared to the expected within lab SD as listed on the Performance Verifier (PV) Assay Sheets.
Reason for recall: Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fluids when compared to the expected within lab SD as listed on the Performance Verifier (PV) Assay Sheets. Distribution: Worldwide distribution - US Nationwide including in the statesof Maine, Massachusetts, Vermont, Connecticut, New Jersey, New York, Pennsylvania, Washington DC, Maryland, Virginia, West Virginia, North Carolina, South Carolina, Georgia, Florida, Alabama, Tennessee, Missouri, Mississippi, Kentucky, Ohio, Indiana, Michigan, Iowa, Wisconsin, Minnesota, South Dakota, North Dakota, Montana, Illinois, Ka Quantity: 73,071 Lot/code info: Lot #s 600203564949, 600203564950, 600203564975, 600203564976, 600203564977, 600203564978, 600203566275, 600203566276, 600203566277, 600203566537, 600203566538, 600203566620, 600203566621, 600203566622, 600203566698, 600203566699, 600203566700, 600203567485, 600203567486, 600203567546, 600203567547, 600303570416, 600303570417, 600303570476, 600303570495, 600303570496, 600303571564, 600303571565, 600303576365, 600303576366, 600303578980, 600303578981, 600303578982, 600303578984, 600303578985, 600303579304, 600303579305, 600303579338, 600303579339, 600303579545, 600303579546, 600303579570, 600303579571, 600503581579, 620503581598, 600503581599, 600503581600, 600503581626, 600503582485, 600503582661, 600503582711, 600503582712, 600503582713, 600503583174, 600503583175, 600503584118, 600503584168, 600503584169, 600503589810, 600503589811, 600503589812, 600603591744, 600603591745, 600603591746, 600603595598, 600603595599, 600603595644, 600603595645, 600603595655, 600603595656, 600603597378, 600603597379, 600603599568, 600603599572, 600603599630, 600803637422, 600803637423, 600803637424, 600803638469, 600803638470
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.