Food, drugs, devices › Ortho-Clinical Diagnostics

Device recall: VITROS Sodium Slides, Catalog # 837 9034

FDA enforcement event 80436 · Class II · initiated 5 May 2018 · status Terminated · terminated 19 Feb 2021

DeviceVoluntary: Firm initiated1 product recordRochester, NY

Ortho-Clinical Diagnostics (Rochester, NY) initiated this device recall on 5 May 2018; FDA lists 1 product record under event 80436, classified Class II.

FDA defines Class II as 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. 92% of the 1,074 device enforcement events initiated in 2018 carry the same class.

Status: Terminated, terminated 19 Feb 2021. Initiation: voluntary: firm initiated. Ortho-Clinical Diagnostics has 105 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Ortho-Clinical Diagnostics, Rochester, NY.

Reason for recall

"Potential for positively biased results"

Distribution

"US Nationwide, Bermuda, Austria, Brazil, Canada, Colombia, China, India, Japan, Mexico, Singapore, UK, France, Germany, Italy, Spain, Portugal, Poland, Russia, Denmark, Norway, Sweden, Belgium and…"

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-3280-2018	VITROS Sodium Slides, Catalog # 837 9034	—	Class II	Terminated	10 Oct 2018

Context

92%of 2018 device events are Class II1,074 events that year

1product record in this eventfirm median: 1

105events on this register for the firm

Other enforcement events for Ortho-Clinical Diagnostics

Initiated	Product (first record)	Type	Class	Records
27 Feb 2024	VITROS Performance Verifier I	Device	Class II	2
5 Jun 2023	VITROS Immunodiagnostic Products Troponin I ES Reagent Pack	Device	Class II	2
8 May 2023	VITROS Chemistry Products Calibrator Kit 20-in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 20- U	Device	Class II	1
20 Jul 2020	VITROS XT3400 Chemistry System, Product code 6844458	Device	Class II	2
17 Jul 2020	VITROS Anti-SARS-CoV-2 Total Reagent, COV2TOT, VITROS CoV2T. Catalog number 6199922, UDI 10758750033386 - Product Usage:	Device	Class II	2
13 Jul 2020	VITROS Chemistry Products TBIL Slides- 5 PACK/300 SLDS In vitro Diagnostic quantitatively measure total bilirubin (TBIL)	Device	Class II	3
20 May 2020	VITROS 3600 Immunodiagnostic System Software Versions 3.3.3 and below Product Code: 6802783, Unique Identifier: 10758750	Device	Class II	5
11 May 2020	VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/300 SLDS, Product Code 1202670, UDI # 10758750008513 - Prod	Device	Class II	4
1 Apr 2020	VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 805 8232-300 slides, UDI Number 10758750004294 -	Device	Class II	2
10 Mar 2020	VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468	Device	Class III	1

All 105 events for Ortho-Clinical Diagnostics

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "Potential for positively biased results"

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is 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.

Where was the product distributed?

FDA's distribution pattern field reads: "US Nationwide, Bermuda, Austria, Brazil, Canada, Colombia, China, India, Japan, Mexico, Singapore, UK, France, Germany, Italy, Spain, Portugal, Poland, Russia, Denmark, Norway, Sweden, Belgium and…"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 19 Feb 2021. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.