Device recall: VITROS Chemistry Products VersaTips, Catalog No. 6801715 A VersaTip sales unit is composed of 1000 tips per box.

Class II FDA enforcement event 89362. Recall start date: 10 Dec 2021. Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

The lot has a shape deformity which may lead to a 16% reduction in the volume of the sample or reagent dispensed. In cases where the error is not detected and the affected results are not suppressed, clinical impact may include reduced drug dosage, or false positive or false negative results for bloodborne infectious disease assays when sample results are close to the cut-off value.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Ortho-Clinical Diagnostics, Inc. started this device recall on 10 Dec 2021. The firm address in the FDA record is in Rochester, NY. FDA put the recall in Class II. FDA event 89362 has 1 product record. The first FDA enforcement report date is 16 Mar 2022. The record gives the status Ongoing.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Domestic distribution nationwide. Foreign distribution to Canada.

Recalling firm

Ortho-Clinical Diagnostics, Inc., Rochester, NY.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 89362: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-0735-2022	VITROS Chemistry Products VersaTips, Catalog No. 6801715 A VersaTip sales unit is composed of 1000 tips per box.	4125 units	Class II	Ongoing	16 Mar 2022

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2021: 900
Share of these events in Class II: 89%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 54

Other events of the firm

Other FDA enforcement events of Ortho-Clinical Diagnostics, Inc.
Initiated	Product (first record)	Type	Class	Records
29 Jul 2025	Chemistry Products LAC Slides. Catalog Number: 8433880. 1 Sales Unit = contains 5 cartridges of 60 slides, for a total o	Device	Class II	2
9 Jul 2025	VITROS Chemistry Products Ca Slides; Catalog Number: 145 0261;	Device	Class II	1
12 Jun 2025	VITROS Chemistry Products OP Reagent Gen 15. Model Number: 680 1997. The VITROS OP Reagent is a dual-chambered package c	Device	Class II	1
10 Jun 2025	Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier I Model/Catalog Numbe	Device	Class II	4
9 May 2025	Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: (1) 6802413, (2) 6802915	Device	Class II	3
14 Apr 2025	VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges, of 18 slides per cartridge, for a total of 9	Device	Class II	1
24 Mar 2025	Brand Name: Solana Bordetella Complete Assay Product Name: Solana Bordetella kit Model/Catalog Number: M308 Software Ver	Device	Class II	1
19 Dec 2024	Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: 6802413 (New), 6802415 (Certified/R	Device	Class II	3
11 Oct 2024	VITROS Chemistry Products CRP Slides- In vitro diagnostic quantitatively measures C-reactive protein (CRP) concentration	Device	Class II	1
10 Jul 2024	The VITROS XT Chemistry Products ALB-TP Slides is a single device that contains both an albumin test and a total protein	Device	Class II	1

Ortho-Clinical Diagnostics, Inc.: all 54 events

Official channels

FDA enforcement report Z-0735-2022The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 89362. https://recallregister.com/fda/ii/89362/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Domestic distribution nationwide. Foreign distribution to Canada.
What quantity of product is in FDA event 89362?: The FDA record gives this quantity: 4125 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2021 have the same class?: 89% of the 900 device events that started in 2021 are in Class II.