Recall Z-1914-2016
Ortho-Clinical Diagnostics · initiated April 6, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: 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
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.
FDA-determined cause: Software design
Action taken
On 4/6/2016,URGENT PRODUCT CORRECTION NOTIFICATION letters (Ref. CL2016-076, dated 4/06/2016) were sent via FedEx overnight and/or US Postal Service Priority Mail (only to those consignees who provided a PO Box as an address) to all customers who received the affected product and advised them of the issue and the required actions. Follow enclosed instructions to help decrease the probability of the software anomaly until the software update is installed. Discuss any concerns with previously report results with their Laboratory Medical Director to determine the appropriate course of action. Install Software Version 3.2.3 at their earliest convenience. Foreign affiliates were informed of the issue by e-mail on 4/6/2016, and instructed to notify their consignees of the issue and required actions.
Details
- Recall number
- Z-1914-2016
- Initiated
- April 6, 2016
- Terminated
- June 1, 2018
- Product code
- JJE – Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Quantity
- VITROS 5600: US: 1161 units, Foreign: 1063 units; VITROS 5600 Refurbished: US: 19 units, Foreign: 38 units
- 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.
- Recalling firm
- Ortho-Clinical Diagnostics, Rochester, NY
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1913-2016 Class II | VITROS 3600 Immunodiagnostic System, Catalog Number 6802783,for use in the in vitro…Ortho Clinical Diagnostics confirmed a software timing anomaly in which the VITROS 3600 and 5600 Systems may… | 04/06/2016Terminated |