CLASS II Device recall · Reported 24 Jun 2020 · FDA Enforcement Report

Vitros Chemistry Product Amyl Slides Reagent recalled

Ortho-Clinical Diagnostics is recalling Vitros Chemistry Product Amyl Slides Reagent, Amylase//300 Slds, distributed nationwide in the US. The recall was initiated on 11 May 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #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

Quantity recalled73,071

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2364-2020
FDA event ID: 85652
Recalling firm: Ortho-Clinical Diagnostics, Rochester, NY
Classification: Class II
Status: Terminated
Recall initiated: 11 May 2020
FDA classified: 15 Jun 2020
Reported: 24 Jun 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Device type: Test Kits & Diagnostics

Timeline

11 May 2020	Recall initiated by company
15 Jun 2020	Classified by FDA	+35 days
24 Jun 2020	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

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.

Where it was distributed

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, Kansas, Nebraska, Louisiana, Arkansas, Oklahoma, Texas, Colorado, Idaho, Utah, Arizona, New Mexico, California, Hawaii, Oregon , Washington, and Alaska

Nationwide Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 85652

This product is part of a recall event; the main page for the event is Vitros Chemistry Product Performance Verifier I, Product recalled.

Reported	Class	Recall	Company	Reason	Where
24 Jun 2020	CLASS II	Vitros Chemistry Product Performance Verifier I, Product recalled	Ortho-Clinical Diagnostics	Potency & Assay	Nationwide
24 Jun 2020	CLASS II	Vitros Chemistry Product Performance Verifier II, Product recalled	Ortho-Clinical Diagnostics	Potency & Assay	Nationwide
24 Jun 2020	CLASS II	Vitros Chemistry Product Amyl Slides Reagent recalled	Ortho-Clinical Diagnostics	Potency & Assay	Nationwide

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