Food, drugs, devices › Ortho-Clinical Diagnostics

Device recall: VITROS Chemistry Products Calibrator Kit 9 Calibrator, 2 mL, Product Code 8568040, Unique Device Identifier No. 10758750

FDA enforcement event 72289 · Class III · initiated 28 Sep 2015 · status Terminated · terminated 22 May 2018

DeviceVoluntary: Firm initiated1 product recordRochester, NY

FDA enforcement event 72289 is a device recall by Ortho-Clinical Diagnostics of Rochester, NY, initiated 28 Sep 2015 and classified Class III, with 1 product record.

FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 4% of the 1,153 device enforcement events initiated in 2015 carry the same class.

Status: Terminated, terminated 22 May 2018. 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

"The firm is conducting a product correction due to an increase in U90-382 or 6LU condition codes (wash errors) when using VITROS Calibrator Kit 9, Lot 0954."

Distribution

"Nationwide, Puerto Rico and foreign distribution to the following countries: Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Republic of…"

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-0202-2016	VITROS Chemistry Products Calibrator Kit 9 Calibrator, 2 mL, Product Code 8568040, Unique Device Identifier No. 10758750005031, IVD -- Ortho Clinical Diagnostics, Inc. --- VITROS Chemistry Products Calibrator Kit 9 is used to calibrate VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600…	Domestic: 2443 kits; Foreign: 1548 kits	Class III	Terminated	11 Nov 2015

Context

4%of 2015 device events are Class III1,153 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: "The firm is conducting a product correction due to an increase in U90-382 or 6LU condition codes (wash errors) when using VITROS Calibrator Kit 9, Lot 0954."

What does Class III mean?

FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

Where was the product distributed?

FDA's distribution pattern field reads: "Nationwide, Puerto Rico and foreign distribution to the following countries: Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Republic of…"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 22 May 2018. "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.