CLASS III Device recall · Reported 11 Nov 2015 · FDA Enforcement Report
Vitros Chemistry Products Calibrator Kit 9 Calibrator, Product recalled
Ortho-Clinical Diagnostics is recalling Vitros Chemistry Products Calibrator Kit 9 Calibrator, Product, distributed nationwide in the US. The recall was initiated on 28 Sep 2015 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-0202-2016
- FDA event ID
- 72289
- Recalling firm
- Ortho-Clinical Diagnostics, Rochester, NY
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 28 Sep 2015
- FDA classified
- 3 Nov 2015
- Reported
- 11 Nov 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 28 Sep 2015 | Recall initiated by company | |
| 3 Nov 2015 | Classified by FDA | +36 days |
| 11 Nov 2015 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The firm is conducting a product correction due to an increase in U90-382 or 6LU condition codes (wash errors) when using VITROS Calibrator Kit 9, Lot 0954.
Product as listed by the FDA
VITROS Chemistry Products Calibrator Kit 9 Calibrator, 2 mL, Product Code 8568040, Unique Device Identifier No. 10758750005031, IVD -- Ortho Clinical Diagnostics, Inc. --- VITROS Chemistry Products Calibrator Kit 9 is used to calibrate VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System for the quantitative measurement of ACET, CRBM, DGXN, and PHYT.
Where it was distributed
Nationwide, Puerto Rico and foreign distribution to the following countries: Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panama, Singapore, Spain and Venezuela
Questions about this recall
Is Vitros Chemistry Products Calibrator Kit 9 Calibrator, Product recalled?
Yes. Ortho-Clinical Diagnostics recalled Vitros Chemistry Products Calibrator Kit 9 Calibrator, Product on 28 Sep 2015. The recall is Class III and its status is Terminated. Recall number Z-0202-2016.
Why was it recalled?
The firm is conducting a product correction due to an increase in U90-382 or 6LU condition codes (wash errors) when using VITROS Calibrator Kit 9, Lot 0954.
Which lots are affected?
Lot 0954, exp. date 31-May-2016
Where was it sold?
Nationwide, Puerto Rico and foreign distribution to the following countries: Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Republic of 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 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 21 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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