Z-2367-2020Class II

VITROS Chemistry Product Performance Verifier II, Product Code 8067324, UDI # 10758750004317 -

Name: Z-2367-2020 VITROS Chemistry Product Performance Verifier II, Product Code 8067324, UDI # 10758750004317 -
Creator: Ortho-Clinical Diagnostics
Published: 2020-05-11
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2020-05-11 / Terminated

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS Chemistry Product Performance Verifier II, Product Code 8067324, UDI # 10758750004317 - Product Usage: For in vitro diagnostic use only to... on 2020-05-11. FDA classified it as Class II and gives the reason as "Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fluids when compared to the expected within lab SD as listed on the Performance Verifier (PV) Assay Sheets". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2367-2020
Classification: Class II
Status: Terminated
Initiated: 2020-05-11
Posted: 2020-06-15
Terminated: 2021-09-22
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS Chemistry Product Performance Verifier II, Product Code 8067324, UDI # 10758750004317 - Product Usage: For in vitro diagnostic use only to quantitatively measure amylase activity in serum, plasma, and urine using VITROS 250/350/5, 1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems.
Product code: CIW Starch-Dye Bound Polymer, Amylase
Reason for recall: Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fluids when compared to the expected within lab SD as listed on the Performance Verifier (PV) Assay Sheets.
FDA root cause: Under Investigation by firm
Action: On May 11, 2020, Ortho Clinical Diagnostics, Inc. sent an Urgent Medical Device Correction Notification to their customers alerting them of important information regarding the precision of VITROS AMYL Slides. The notice stated that the imprecision affects serum, urine and QC samples, however VITROS AMYL Slides performance continues to meet its intended clinical use. The VITROS Performance Verifiers I and II Control Assay Sheet estimated within-lab SD, Range of Means (ROM) and Delta table values were re-evaluated. The Delta tables will be updated in a future revision of the Performance Verifier Training Module. In the meantime, customers were instructed to use the revised estimated within-lab SD listed in the enclosed Information sheet to evaluate their lab's quality control when using VITROS Performance Verifier I and II products. When available on the Ortho website, https://www.orthoclinicaldiagnostics.com, customers can obtain the updated VITROS Performance Verifier Control Assay Sheets and can use the revised ROM to evaluate the labs VITROS AMYL Slide quality control when using VITROS Performance Verifier I and II products. The firm explained that a review of previously reported patient results is NOT recommended. The customers were asked to Complete the Confirmation of Receipt form no later than May 19, 2020 and to forward the notification if the product was distributed outside of their facility.
Distribution: Worldwide distribution - US Nationwide including in the statesof Maine, Massachusetts, Vermont, Connecticut, New Jersey, New York, Pennsylvania, Washington DC, Maryland, Virginia, West Virginia, North Carolina, South Carolina, Georgia, Florida, Alabama, Tennessee, Missouri, Mississippi, Kentucky, Ohio, Indiana, Michigan, Iowa, Wisconsin, Minnesota, South Dakota, North Dakota, Montana, Illinois, Kansas, Nebraska, Louisiana, Arkansas, Oklahoma, Texas, Colorado, Idaho, Utah, Arizona, New Mexico, California, Hawaii, Oregon , Washington, and Alaska
Product codes and lots: Current Control Assay Sheet SD 10.5, 10.8 Revised Control Assay Sheet 17.1, 17.6

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2367-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2364-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-24	2020-06-15
Z-2365-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-24	2020-06-15
Z-2366-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-24	2020-06-15
Z-2367-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-24	2020-06-15

Product code CIW

K812027Class IIKodak Ektachem Clin. Chem. Slides (Amyl)Eastman Kodak Company / cleared 1981-08-03

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)