CLASS II Device recall · Reported 13 Nov 2019 · FDA Enforcement Report

Vitros chemistry Products K+ Slides recalled

Ortho-Clinical Diagnostics is recalling Vitros chemistry Products K+ Slides, distributed nationwide in the US. The recall was initiated on 10 Sep 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes410209876551 410209876548 410209876539 410209950186 410209950196 410209950232 410209960354 410209960373 410209960330 410209960477 410209960495 410209970685 410209970716 410209970763 410209960548 410209960590 410209960591 410209960625 410209960626 410209970818 410209971322 410209971446 410209971447 410209971483 410209971484 410209971485 410209971602 410209971699 410209981652 410209981767 410209991938 410209991939 410210003291 410210003396 410210003507 410210003510 410210023496 410210023498 410210003645 410210003669 410210003719 410210003775 410210013798 410210013912 410210013938 410210013966 410210013996 410210014061 410210014053 410210024095 410210014134 410210024167 410210024196 410210024284 410210024342 410210024403 410210024438 410210024469 410210024506 410210044598 410210054742 410210044699 410210044700 410210044751 410210044842 410210045037 410210045051 410210045095 410210045097 410210045186 410210055198 410210055249 410210055278 410210085927 410210085928 410210085986 410210086101 410210086109 410210086142 410210086198 410210086287 410210086304 410210096368 410210096494 410210096478 410210096588 410210096658 410210096686 410210096701 410210096723 410210066822 410210066936 410210066947 410210066992 410210067044 410210067073 410210067109 410210067201 410210067205 410210067287 410210067304 410210107327 410210137302 410210107400 410210107489 410210107514 410210107551 410210107603 410210107673 410210107674 410210127698 410210127910 410210127985 410210127978 410210128212 410210138441 410210138469 410210138500 410210148567 410210148628 410210148716 410210148756 410210149025 410210149031 410210149051 410210149085 410210149117 410210149118 410210159091 410210159112 410210159179 410210159232 410210159262 410210159277 410210169332 410210169337 410210169383 410210169384 410210169431 410210169485 410210189482 410210169504 410210169548 410210169628 410210169681 410210169705 410210169775 410210169822 410210169840 410210179951 410210169870 410210179976 410210179986 410210170029 410210160143 410210180175 410210190174 410210180214 410210180297 410210180349 410210180374 410210180376 410210180454 410210200457 410210180492 410210180493 410210180632 410210190649 410210180652 410210180686 410210190676 410210190808 410210190828 410210190892

Quantity recalled1365545 total

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-0269-2020
FDA event ID: 83879
Recalling firm: Ortho-Clinical Diagnostics, Rochester, NY
Classification: Class II
Status: Terminated
Recall initiated: 10 Sep 2019
FDA classified: 1 Nov 2019
Reported: 13 Nov 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Test Kits & Diagnostics

Timeline

10 Sep 2019	Recall initiated by company
1 Nov 2019	Classified by FDA	+52 days
13 Nov 2019	Published in enforcement report	+12 days

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

Reason for recall

Users may experience intermittent slide dispense issues with some cartridges due to the anti-backup platen failing to advance inside the cartridge.

Product as listed by the FDA

VITROS chemistry Products K+ Slides, Catalog No. 8157596. MicroSlides which contain reagents in a dry, multi-layered form.

Where it was distributed

Domestic distribution nationwide. Foreign distribution to Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, the Netherlands, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, and United Kingdom.

Nationwide

Questions about this recall

Why was it recalled?

Users may experience intermittent slide dispense issues with some cartridges due to the anti-backup platen failing to advance inside the cartridge.

Which lots are affected?

410209876551 410209876548 410209876539 410209950186 410209950196 410209950232 410209960354 410209960373 410209960330 410209960477 410209960495 410209970685 410209970716 410209970763 410209960548 410209960590 410209960591 410209960625 410209960626 410209970818 410209971322 410209971446 410209971447 410209971483 410209971484 410209971485 410209971602 410209971699 410209981652 410209981767 410209991938 410209991939 410210003291 410210003396 410210003507 410210003510 410210023496 410210023498 410210003645 410210003669 410210003719 410210003775 410210013798 410210013912 410210013938 410210013966 410210013996 410210014061 410210014053 410210024095 410210014134 410210024167 410210024196 410210024284 410210024342 410210024403 410210024438 410210024469 410210024506 410210044598 410210054742 410210044699 410210044700 410210044751 410210044842 410210045037 410210045051 410210045095 410210045097 410210045186 410210055198 410210055249 410210055278 410210085927 410210085928 410210085986 410210086101 410210086109 410210086142 410210086198 410210086287 410210086304 410210096368 410210096494 410210096478 410210096588 410210096658 410210096686 410210096701 410210096723 410210066822 410210066936 410210066947 410210066992 410210067044 410210067073 410210067109 410210067201 410210067205 410210067287 410210067304 410210107327 410210137302 410210107400 410210107489 410210107514 410210107551 410210107603 410210107673 410210107674 410210127698 410210127910 410210127985 410210127978 410210128212 410210138441 410210138469 410210138500 410210148567 410210148628 410210148716 410210148756 410210149025 410210149031 410210149051 410210149085 410210149117 410210149118 410210159091 410210159112 410210159179 410210159232 410210159262 410210159277 410210169332 410210169337 410210169383 410210169384 410210169431 410210169485 410210189482 410210169504 410210169548 410210169628 410210169681 410210169705 410210169775 410210169822 410210169840 410210179951 410210169870 410210179976 410210179986 410210170029 410210160143 410210180175 410210190174 410210180214 410210180297 410210180349 410210180374 410210180376 410210180454 410210200457 410210180492 410210180493 410210180632 410210190649 410210180652 410210180686 410210190676 410210190808 410210190828 410210190892

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

2 other products · FDA event 83879

This product is part of a recall event; the main page for the event is Vitros chemistry Products Cl- Slides recalled.

Reported	Class	Recall	Company	Reason	Where
13 Nov 2019	CLASS II	Vitros chemistry Products Cl- Slides recalled	Ortho-Clinical Diagnostics	Device Malfunction	Nationwide
13 Nov 2019	CLASS II	Vitros chemistry Products Cl- Slides recalled	Ortho-Clinical Diagnostics	Other	Nationwide

More recalls from Ortho-Clinical Diagnostics

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Reported	Class	Recall	Company	Reason	Where
24 Sep 2025Device	CLASS II	Chemistry Products LAC Slides recalled by Ortho-Clinical Diagnostics	Ortho-Clinical Diagnostics	Device Malfunction	Nationwide
24 Sep 2025Device	CLASS II	Vitros Chemistry Products LAC Slides recalled	Ortho-Clinical Diagnostics	Device Malfunction	Nationwide
27 Aug 2025Device	CLASS II	Vitros Chemistry Products Ca Slides recalled	Ortho-Clinical Diagnostics	Device Malfunction	Nationwide
23 Jul 2025Device	CLASS II	Vitros Chemistry Products CHE Slides (Japan) recalled	Ortho-Clinical Diagnostics	Labeling Errors	Nationwide
23 Jul 2025Device	CLASS II	Vitros Chemistry Products CHE Slides recalled	Ortho-Clinical Diagnostics	Labeling Errors	Nationwide

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