Z-3193-2018Class III

VITROS Chemistry Products CREA Slides, Product Code 680 2584

Name: Z-3193-2018 VITROS Chemistry Products CREA Slides, Product Code 680 2584
Creator: Ortho-Clinical Diagnostics
Published: 2018-07-11
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2018-07-11 / Terminated / root cause: manufacturing process

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS Chemistry Products CREA Slides, Product Code 680 2584 Product Usage: VITROS CREA Slides (Product Code 680 2584) - For in vitro diagnostic use only... on 2018-07-11. FDA classified it as Class III and gives the reason as "The slides did not meet the current claims for Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantification (LoQ) for serum and urine samples and therefore affecting the low end of the measuring range for...". 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-3193-2018
Classification: Class III
Status: Terminated
Initiated: 2018-07-11
Posted: 2018-09-19
Terminated: 2020-08-19
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS Chemistry Products CREA Slides, Product Code 680 2584 Product Usage: VITROS CREA Slides (Product Code 680 2584) - For in vitro diagnostic use only. VITROS Chemistry Products CREA Slides quantitatively measure creatinine (CREA) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
Product code: JFY Enzymatic Method, Creatinine
Reason for recall: The slides did not meet the current claims for Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantification (LoQ) for serum and urine samples and therefore affecting the low end of the measuring range for this assay. The current low end measuring range is 0.05mg/dL for serum and 1.2mg/dL for urine. Based on the CREA testing results for the LoQ, the revised low end CREA measuring range is 0.15mg/dL for serum and 3.2mg/dL for urine.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 7/11/18, Important Product Correction Notification letters were distributed to customers. The letters instructed customers to perform the following actions: VITROS Cl- Slides and VITROS CREA Slides Instructions for Use will be updated to contain the revised information described in this letter; we will notify you upon availability. In the interim, retain a copy of this customer letter for your records. Calibration Diskette and ADD Data Release Version (DRV) 5992 (and above) will support the revised measuring range for VITROS CREA Slides. We anticipate that DRV 5992 will be available beginning on July 28, 2018 by eConnectivity or will be sent via your normal Cal Disk or ADD mailing. Prior to the availability of the revised IFU, be aware that if a serum or plasma sample contains a Triglyceride concentration of 600 mg/dL or higher, the Chloride result may be positively biased by approximately 2.1 mmol/L. Follow your normal laboratory procedures as you would for other known assay interferences. Note: It is acceptable to continue using VITROS Cl- Slides. Upon availability, install the Calibration Diskette or ADD to implement the revised Measuring Range: For VITROS 4600, 5600 or 5,1 FS Systems: Install ADD DRV 5992 or above, Select All Assay Data option For VITROS 250/350 Systems: Install Calibration Diskette DRV 5992 or above Refer to the enclosure for additional instructions to update the Measuring Range. Update laboratory procedures and your Laboratory Information System (LIS), as necessary. Retain this letter until we send a notification to alert you when the revised IFUs are available. Complete the Confirmation of Receipt form and return by July 25, 2018. Post this notification by each system that processes VITROS Cl- or CREA Slides. Forward this notification if the product was distributed outside of your facility.
Quantity in commerce: 627543
Distribution: Worldwide distribution. US nationwide, Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, and United Kingdom.
Product codes and lots: GEN 7, GEN 10, GEN 12, GEN 13, GEN 15, GEN 16, GEN 18

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3193-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3193-2018	Class III	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-18

Product code JFY

K063591Class IIVitros Chemistry Products Crea Slides,model# 6802584, Vitros Chemistry Products Calibrator Kit 1,Model#1882208Ortho-Clinical Diagnostics, Inc. / cleared 2006-12-15

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)