CLASS III Device recall · Reported 13 Jul 2016 · FDA Enforcement Report
Vitros Chemistry Products Calibrator Kit recalled
Ortho-Clinical Diagnostics is recalling Vitros Chemistry Products Calibrator Kit 29, distributed nationwide in the US. The recall was initiated on 24 May 2016 and the FDA has classified it as Class III.
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-2119-2016
- FDA event ID
- 74363
- Recalling firm
- Ortho-Clinical Diagnostics, Rochester, NY
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 24 May 2016
- FDA classified
- 1 Jul 2016
- Reported
- 13 Jul 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 24 May 2016 | Recall initiated by company | |
| 1 Jul 2016 | Classified by FDA | +38 days |
| 13 Jul 2016 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Ortho Clinical Diagnostics started receiving customer complaints for biased results when using VITROS dTIBC Reagent GEN 30 product. Ortho's investigation confirmed that incorrect calibration mathematics were assigned to the Calibrator Kit 29 Lots 2915 and 2995 supporting dTIBC Reagent GEN 30 product.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
VITROS Chemistry Products Calibrator Kit 29, REF/Product Code 680 2344, used in conjunction with VITROS Chemistry Products dTIBC Reagent Generation 30 (GEN 30), REF 680 2001, and Assay Data Disk (ADD), REF/Product Code 6801876 (Unique Device No. 10758750001576), Data Release Versions (DRVs) 5870 through 5883 inclusive; IVD --- Ortho-Clinical Diagnostics For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 29 is used to calibrate the VITROS 5,1 FS Chemistry System, the VITROS 4600 Chemistry System and the VITROS 5600 Integrated System for the quantitative measurement of total iron-binding capacity (TIBC) using VITROS Chemistry Products dTIBC Reagent.
Where it was distributed
Worldwide Distribution - US (Nationwide, Puerto Rico) and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, Poland, and Venezuela.
Questions about this recall
Why was it recalled?
Ortho Clinical Diagnostics started receiving customer complaints for biased results when using VITROS dTIBC Reagent GEN 30 product. Ortho's investigation confirmed that incorrect calibration mathematics were assigned to the Calibrator Kit 29 Lots 2915 and 2995 supporting dTIBC Reagent GEN 30 product.
Which lots are affected?
Lots 2915 (exp. December 2016) and 1995 (exp. July 2016)
Where was it sold?
Worldwide Distribution - US (Nationwide, Puerto Rico) and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, Poland, 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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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.
More recalls from Ortho-Clinical Diagnostics
All 311| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Chemistry Products LAC Slides recalled by Ortho-Clinical Diagnostics | Ortho-Clinical Diagnostics | Device Malfunction | Nationwide |
| Device | CLASS II | Vitros Chemistry Products LAC Slides recalled | Ortho-Clinical Diagnostics | Device Malfunction | Nationwide |
| Device | CLASS II | Vitros Chemistry Products Ca Slides recalled | Ortho-Clinical Diagnostics | Device Malfunction | Nationwide |
| Device | CLASS II | Vitros Chemistry Products CHE Slides (Japan) recalled | Ortho-Clinical Diagnostics | Labeling Errors | Nationwide |
| Device | CLASS II | Vitros Chemistry Products CHE Slides recalled | Ortho-Clinical Diagnostics | Labeling Errors | Nationwide |
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