CLASS II Device recall · Reported 30 Apr 2014 · FDA Enforcement Report
Vitros Chemistry Products Cdm Prom recalled
Ortho-Clinical Diagnostics is recalling Vitros Chemistry Products Cdm Prom (Calibration Data Module) No. 0168, distributed in 10 states. The recall was initiated on 29 Jan 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1490-2014
- FDA event ID
- 67509
- Recalling firm
- Ortho-Clinical Diagnostics, Rochester, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Jan 2014
- FDA classified
- 23 Apr 2014
- Reported
- 30 Apr 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Test Kits & Diagnostics
Timeline
| 29 Jan 2014 | Recall initiated by company | |
| 23 Apr 2014 | Classified by FDA | +84 days |
| 30 Apr 2014 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Customers were unable to calibrate, or use previously calibrated, VITROS DT CRSC slides (REF/Product Code 6802721), GEN 82, on the VITROS DT II System, when using Calibration Data Module (CDM) Rev. 168 (REF/Product Code 199 9077), as CDM 168 does not contain calibration parameters for DT CRSC.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
VITROS Chemistry Products CDM PROM (Calibration Data Module) No. 0168, Catalog Number/REF 199 9077, used in conjunction with: VITROS Chemistry Products CRSC DT Slides, Generation (GEN) 82, REF 6802721, and VITROS DT Calibrator Kit, Product Code 1957924, and tested on the VITROS DT60/DT60 II Chemistry System; IVD --- Ortho-Clinical Diagnostics, Inc.
Where it was distributed
Worldwide Distribution - US Distribution including the states of AR, FL, IA, IL, KY, MI, MN, ND, NY and VA, and the countries of Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela.
ArkansasFloridaIowaIllinoisKentuckyMichiganMinnesotaNorth DakotaNew YorkVirginia
Questions about this recall
Why was it recalled?
Customers were unable to calibrate, or use previously calibrated, VITROS DT CRSC slides (REF/Product Code 6802721), GEN 82, on the VITROS DT II System, when using Calibration Data Module (CDM) Rev. 168 (REF/Product Code 199 9077), as CDM 168 does not contain calibration parameters for DT CRSC.
Which lots are affected?
Calibration Data Module Rev. 0168, REF 199 9077 used in conjuction with of VITROS Chemistry Products CRSC DT Slides, Generation (GEN) 82, Product Code 6802721.
Where was it sold?
Worldwide Distribution - US Distribution including the states of AR, FL, IA, IL, KY, MI, MN, ND, NY and VA, and the countries of Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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