Z-1473-04

VITROS CRP Slides: (1) Cat # 192 6740, 250 slides per box, and (2) Cat # 809 7990, 90 slides per box. Firm on...

Name: Z-1473-04 VITROS CRP Slides: (1) Cat # 192 6740, 250 slides per box, and (2) Cat # 809 7990, 90 slides per box. Firm on...
Creator: Ortho-Clinical Diagnostics
Published: 2004-07-28
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2004-07-28 / Terminated / root cause: software

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS CRP Slides: (1) Cat # 192 6740, 250 slides per box, and (2) Cat # 809 7990, 90 slides per box. Firm on the label: Ortho-Clinical Diagnostics, Inc... on 2004-07-28. The reason FDA records is "The Immuno-rate (IR) wash detection algorithm may result in inappropriate wash detections". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1473-04
Status: Terminated
Initiated: 2004-07-28
Posted: 2004-09-18
Terminated: 2005-06-09
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS CRP Slides: (1) Cat # 192 6740, 250 slides per box, and (2) Cat # 809 7990, 90 slides per box. Firm on the label: Ortho-Clinical Diagnostics, Inc., Rochester, NY 14626. The CRP Slides are for use on the Vitros 250/250AT and/or Vitros 950/950AT Clinical Chemistry Systems. For in vitro diagnostic use. Vitros CRP slides quantitatively measure C-reactive protein concentration in serum and plasma.
Product code: DCK C-Reactive Protein, Antigen, Antiserum, And Control
Reason for recall: The Immuno-rate (IR) wash detection algorithm may result in inappropriate wash detections.
Root cause tag: software
FDA root cause: Other
Action: Letters dated 7/28/2004. Distributors instructed to destroy product. Users instructed to use revised IR wash tolerance values (provided with letter). A Calibration Diskette, Data Release Version 5384 will also be provided to end users.
Quantity in commerce: Cat 192 6740 - 5,912 cartons x 250 slides; Cat #809 7990 - 10,344 x 90 slides
Distribution: DOMESTIC distribution (nationwide): Product shipped to 6 distributors, 140 hospitals, and 6 U.S. government accounts. FOREIGN distribution: Product shipped to 22 Ortho-Clinical/J&J affiliates in Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Peru, Ecuador, India, Japan, Mexico, Puerto Rico, Panama, Singapore, Venezuela, England, France, Germany, Italy and Spain. The foreign affiliates further distributed product.
Product codes and lots: Coatings 401 thru 409 (Generations 92, 93, 94, 99, 01, 02, 03, 04, and 05)

Product code DCK

K030626Class IIVitros Chemistry Products Crp Slide and Calibrator Kit 7Ortho-Clinical Diagnostics, Inc. / cleared 2003-03-18

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)