Ortho-Clinical Diagnostics 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Ortho-Clinical Diagnostics
Lot Codes / Batch Numbers
Coatings 401 thru 409 (Generations 92, 93, 94, 99, 01, 02, 03, 04, and 05)
Products Sold
Coatings 401 thru 409 (Generations 92, 93, 94, 99, 01, 02, 03, 04, and 05)
Ortho-Clinical Diagnostics is recalling VITROS CRP Slides: (1) Cat # 192 6740, 250 slides per box, and (2) Cat # 809 7990, 90 slides per box due to The Immuno-rate (IR) wash detection algorithm may result in inappropriate wash detections.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The Immuno-rate (IR) wash detection algorithm may result in inappropriate wash detections.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026