Z-2804-2016Class III

The VITROS Chemistry Products Calibrator Kit 31, Lot 3155 used in conjunction with: VITROS Chemistry Products...

Name: Z-2804-2016 The VITROS Chemistry Products Calibrator Kit 31, Lot 3155 used in conjunction with: VITROS Chemistry Products...
Creator: Ortho-Clinical Diagnostics
Published: 2016-04-19
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2016-04-19 / Terminated / root cause: manufacturing process

FDA source

Ortho-Clinical Diagnostics began a recall of The VITROS Chemistry Products Calibrator Kit 31, Lot 3155 used in conjunction with: VITROS Chemistry Products HbA1c Reagent Kit, Generation 6 (GEN 6) and Assay... on 2016-04-19. FDA classified it as Class III and gives the reason as "There is an incorrect value (data/calibration mathematics) on ADDs. This incorrect value will prevent a successful calibration of the assay". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2804-2016
Classification: Class III
Status: Terminated
Initiated: 2016-04-19
Posted: 2016-09-15
Terminated: 2018-06-08
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: The VITROS Chemistry Products Calibrator Kit 31, Lot 3155 used in conjunction with: VITROS Chemistry Products HbA1c Reagent Kit, Generation 6 (GEN 6) and Assay Data Disk (ADD), Data Release Versions (DRV) 5873, 5874, 5875, or 5876, is used to calibrate the VITROS 5,1 FS Chemistry System, VITROS 4600 Chemistry System and the VITROS 5600 Integrated System for the determination of percent glycated hemoglobin (HbA1c) in human whole blood.
Product code: JIT Calibrator, Secondary
Reason for recall: There is an incorrect value (data/calibration mathematics) on ADDs. This incorrect value will prevent a successful calibration of the assay.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: On 19 April 2016, Ortho Clinical Diagnostics distributed Correction Notification letters (Ref. CL2016-087) and ADD DRV 5877 notices to their US consignees via courier service and to their foreign affiliates via email. Customers were advised to install the Assay Data Diskette DRV 5877 or above on their VITROS system. Following a successful calibration and quality control assessment, it is acceptable to use VITROS HbA1c Reagent Kit, GEN 06. Customers who further distributed the product should also provide a copy of the enclosed letter to all customers who received the product. It is suggested that customers complete and return the Confirmation of Receipt form to indicate that you have been informed of this issue. Customers with questions can contact the Technical Solutions Center at 1-800-421-3311.
Quantity in commerce: 520 Units
Distribution: Worldwide Distribution - US Nationwide in the states of: AL, AR, AZ, CA, CT, DC, FL, GA, IL, IN, KY, LA, MD, MI, MO, MS, NC, NY, OH, OK, OR, PA, SC, TN, TX, WA, WV & Puerto Rico;** Foreign: Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy & Spain.
Product codes and lots: Lot 3155 Product Codes: 6842906 & 6801876

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2804-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2804-2016	Class III	Terminated	Voluntary: Firm initiated	2016-09-21	2016-09-14

Product code JIT

K142595Class IIVITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31, VITROS Chemistry Products %A1c Performance Verifiers I and IIOrtho Clinical Diagnostics / cleared 2015-06-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)