medical Class II Updated 2020-06-24

Ortho-Clinical Diagnostics recalls VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK

Recalled 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 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems.

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
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
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