VITROS 4600 Chemistry System, Software Version 3.2 & Below. Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use.
Reported: June 17, 2015 Initiated: April 6, 2015 #Z-1742-2015
Product Description
VITROS 4600 Chemistry System, Software Version 3.2 & Below. Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use.
Reason for Recall
Software anomaly allows testing of multiple assays using a single urine specimen, regardless of the pretreatment requirements for each selected assay, potentially leading to biased patient results.
Details
- Recalling Firm
- Ortho-Clinical Diagnostics
- Units Affected
- 255 units total (131 domestically & 255 internationally)
- Distribution
- Worldwide Distribution-US (nationwide), Brazil, Chile, Mexico, Australia, Hong Kong, India, Taiwan, Belgium, Denmark, France, Ireland, Italy, Portugal, Romania, Spain, Sweden and the UK.
- Location
- Rochester, NY
Frequently Asked Questions
What product was recalled? ▼
VITROS 4600 Chemistry System, Software Version 3.2 & Below. Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use.. Recalled by Ortho-Clinical Diagnostics. Units affected: 255 units total (131 domestically & 255 internationally).
Why was this product recalled? ▼
Software anomaly allows testing of multiple assays using a single urine specimen, regardless of the pretreatment requirements for each selected assay, potentially leading to biased patient results.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 17, 2015. Severity: Moderate. Recall number: Z-1742-2015.
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