VITROS 3600 Immunodiagnostic System, Catalog Number 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.
Check against the official notice below — it lists the full affected range.
Ortho Clinical Diagnostics has recalled the VITROS 3600 Immunodiagnostic System due to a software timing anomaly. The affected systems may unexpectedly aspirate from or dispense into an unintended sample, which could produce erroneous or contaminated test results. The recall involves 218 units distributed in the United States and 587 units distributed internationally to countries including Australia, Brazil, Canada, China, France, Germany, India, Italy, Japan, Mexico, Singapore, Spain, and Venezuela. The affected devices have Software Version 3.2.2 or below and serial numbers ranging from J36000012 to J36000933.
The source document does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Ortho Clinical Diagnostics confirmed a software timing anomaly in which the VITROS 3600 and 5600 Systems may unexpectedly aspirate from or dispense into an unintended sample that may lead to erroneous or contaminated results.
Reason for recall: Ortho Clinical Diagnostics confirmed a software timing anomaly in which the VITROS 3600 and 5600 Systems may unexpectedly aspirate from or dispense into an unintended sample that may lead to erroneous or contaminated results. Distribution: Nationwide, Puerto Rico and Foreign distribution to the following countries: Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela. Quantity: US: 218 units, Foreign: 587 units Lot/code info: Software Version 3.2.2 & below; Serial Numbers J36000012 - J36000933.Unique Device Identifier No. 10758750002979, IVD.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.