VITROS¿ 3600 Immunoassay System-Software V3.3.2 & below Product Code: 6802783 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents
Reported: May 15, 2019 Initiated: February 20, 2019 #Z-1289-2019
Product Description
VITROS¿ 3600 Immunoassay System-Software V3.3.2 & below Product Code: 6802783 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents
Reason for Recall
Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems
Details
- Recalling Firm
- Ortho-Clinical Diagnostics
- Units Affected
- 267 units
- Distribution
- Worldwide Distribution: US (Nationwide) and countries of: Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden,The Netherlands, and United Kingdom.
- Location
- Rochester, NY
Frequently Asked Questions
What product was recalled? ▼
VITROS¿ 3600 Immunoassay System-Software V3.3.2 & below Product Code: 6802783 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents. Recalled by Ortho-Clinical Diagnostics. Units affected: 267 units.
Why was this product recalled? ▼
Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 15, 2019. Severity: Moderate. Recall number: Z-1289-2019.
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