VITROS 5600 Integrated System, Catalog Number 6802413, Unique Device Identifier No. 10758750002740; and VITROS 5600 Integrated System (refurbished), Catalog Number 6802915, Unique Device Identifier No. 10758750007110; IVD.
Check against the official notice below — it lists the full affected range.
Ortho Clinical Diagnostics recalled VITROS 5600 Integrated Systems and refurbished VITROS 5600 Integrated Systems due to a software timing anomaly. The anomaly may cause these laboratory testing systems to unexpectedly take samples from or dispense into the wrong sample container, potentially resulting in erroneous test results or contaminated samples. A total of 1,161 VITROS 5600 units and 19 refurbished units were distributed in the United States, along with 1,063 VITROS 5600 units and 38 refurbished units distributed internationally to countries including Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela.
The affected devices include VITROS 5600 systems with software version 3.2.2 and below, with serial numbers J56000024 through J56002387, as well as specific refurbished models identified by their individual serial numbers. The recall record does not specify what actions affected consumers or facilities should take in response to this recall.
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: VITROS 5600: US: 1161 units, Foreign: 1063 units; VITROS 5600 Refurbished: US: 19 units, Foreign: 38 units Lot/code info: Software Version 3.2.2 & below; VITROS 5600 Serial Numbers J56000024 - J56002387; VITROS 5600 (Refurbished) US Serial Numbers: 56000186, 56000308, 56000315, 56000327, 56000339, 56000458, 56000559, 56000718, 56000727, 56000741, 56000747, 56000750, 56000786, 56000792, 56000824, 56001062, 56001235, 56001635, 56001641; Foreign Serial Numbers: 56000147, 56000200, 56000214, 56000245,56000283, 56000330, 56000331, 56000362, 56000377, 56000399, 56000413, 56000416, 56000428, 56000437, 56000438, 56000439, 56000459, 56000463, 56000464, 56000466, 56000515, 56000528, 56000537, 56000555, 56000560, 56000632, 56000642, 56000669, 56000680, 56000749, 56000867, 56001133, 56001135, 56001246, 56001461, 56001482, 56001487, 56001859. Unique Device Identifier No. 10758750002740
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.