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 Chemistry Systems and VI
Check against the official notice below — it lists the full affected range.
Ortho-Clinical Diagnostics has recalled VITROS Chemistry Product AMYL Slides Reagent (Product Code 8112724) due to multiple coatings showing imprecision on control fluids when compared to expected performance standards listed on Performance Verifier Assay Sheets. The affected product is intended for in vitro diagnostic use only. Approximately 64,697 units across 53 specific lot numbers have been distributed worldwide, including throughout the United States.
The recall affects numerous lot numbers ranging from 600203565250 through 600803639091. The source document does not specify a remedy or recommended action 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: 64,697 Lot/code info: Lot #s 600203565250, 600203565563, 600203565573, 600203565902, 600203566266, 600203566278, 600203566676, 600203567387, 600203567388, 600203567389, 600303570323, 600303570338, 600303570824, 600303570830, 600303570847, 600303570848, 600303577945, 600303578593, 600303579040, 600303579041, 600303579565, 600303579566, 600303579616, 600503581489, 600503581495, 600503582261, 600503582262, 600503582269, 600503582570, 600503582607, 600503583117, 600503584003, 600503584704, 600503584705, 600503584706, 600503584987, 600503585015, 600503585951, 600503585957, 600503586204, 600503586207, 600503586219, 600603594331, 600603596567, 600603596601, 600603596692, 600603596693, 600803638425, 600803638426, 600803638483, 600803638489, 600803638490, 600803639060, 600803639078, 600803639091
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.