FDAFDA · Food and drugs·Recall number Z-1914-2016
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.
Published June 15, 2016 · Recall initiated: April 6, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Ortho-Clinical Diagnostics
- Distributor
- 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.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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