Z-0864-2017Class III

VITROS CRP Slides: 1) VITROS Chemistry Products CRP Slides (250 slides per sales unit), Catalog # 1926740 and...

Name: Z-0864-2017 VITROS CRP Slides: 1) VITROS Chemistry Products CRP Slides (250 slides per sales unit), Catalog # 1926740 and...
Creator: Ortho-Clinical Diagnostics
Published: 2016-10-26
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2016-10-26 / Terminated / root cause: manufacturing process

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS CRP Slides: 1) VITROS Chemistry Products CRP Slides (250 slides per sales unit), Catalog # 1926740 and 2) , VITROS Chemistry Products CRP Slides (90... on 2016-10-26. FDA classified it as Class III and gives the reason as "CRP samples diluted using VITROS Chemistry Products Specialty Diluent, VITROS Chemistry Products FS Diluent Pack 3, or a sample with a low concentration of CRP had positively biased results if the endogenous level of...". 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-0864-2017
Classification: Class III
Status: Terminated
Initiated: 2016-10-26
Posted: 2016-12-21
Terminated: 2018-06-22
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS CRP Slides: 1) VITROS Chemistry Products CRP Slides (250 slides per sales unit), Catalog # 1926740 and 2) , VITROS Chemistry Products CRP Slides (90 slides per sales unit), Catalog # 1926740
Product code: DCK C-Reactive Protein, Antigen, Antiserum, And Control
Reason for recall: CRP samples diluted using VITROS Chemistry Products Specialty Diluent, VITROS Chemistry Products FS Diluent Pack 3, or a sample with a low concentration of CRP had positively biased results if the endogenous level of CRP in the diluent is not subtracted from the final result. The IFUs do not provide specific instructions for how to account for endogenous CRP in the diluent when calculating the sample result. Orthos diluents used to dilute samples containing CRP are manufactured using human plasma based fluids that contain endogenous CRP. Without accounting for the CRP in the diluent and removing its contribution from the result, the reported result will include the CRP present in both the sample and diluent, possibly leading to positively biased results.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Ortho Clinical Diagnostics sent an Important Product Correction Notification dated October 26, 2016., via FedEx overnight courier and/ or US Postal Service Priority Mail (for PO Boxes only) to all customers who do NOT use ORTHO PLUS e-Communications and received CRP slides within the last 12 months to inform them of the possibility of positively biased CRP results when using VITROS CRP Slides with diluted samples and to provide them with original instructions for how to perform dilutions when processing CRP samples with concentrations above the measuring range. On 1 November 2016, Ortho Clinical Diagnostics issued customer letter (Ref. CL2016-209) sent via ORTHO PLUS e-Communications to all customers who use ORTHO PLUS e-Communications and received CRP slides within the last 12 months to inform them of the possibility of positively biased CRP results when using VITROS CRP Slides with diluted samples and to provide them with two revised instructions on how to perform dilutions when processing CRP samples with concentrations above the measuring range. Foreign affiliates were informed by email on October 26, 2016, of the issue and instructed to notify their consignees of the issue. This included the original instructions for how to perform dilutions when processing CRP samples with concentrations above the measuring range. On 1 November 2016, two revised Instructions for CRP Dilutions enclosures (Ref. CL2016-209) were sent via FedEx overnight courier and/ or US Postal Service Priority Mail (for PO Boxes only) to all customers who received CL2016-209 via FedEx overnight courier or US Postal Service Priority Mail that provided additional detailed instructions on how to perform a dilution for samples exceeding the measuring range. If you have further questions, please contact our Ortho Care Technical Solutions Center at 1-800-421-3311.
Quantity in commerce: 124,063 units
Distribution: Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico, and to the countries of : Bermuda, Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain and Poland.
Product codes and lots: Affected Generations (GENs): 3, 11, 12, 30 through 36

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0864-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0864-2017	Class III	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-21

Product code DCK

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)