FDA Device recall Z-0080-2019
VITROS 5600 Integrated System- (Refurbished)
- FDA Device
- Class II
- terminated
- Published 2018-10-17
On 2018-10-17 the FDA classified a Class II recall of VITROS 5600 Integrated System- (Refurbished) by Ortho Clinical Diagnostics, citing potential for the VITROS 5600 Integrated System to dispense an insufficient sample volume onto a MicroSlide without suppressing the potentially incorrect result.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0080-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-08-15 |
| Published | 2018-10-17 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | US |
Product
VITROS 5600 Integrated System- (Refurbished). For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, Catalog Number: 6802915
Reason
Potential for the VITROS 5600 Integrated System to dispense an insufficient sample volume onto a MicroSlide without suppressing the potentially incorrect result.
Identifiers
| code_info | Serial Numbers: US: 56000718 56001062 56000458 56000824 56000315 56001235 56000786 56000747 56000339 5600055…Serial Numbers: US: 56000718 56001062 56000458 56000824 56000315 56001235 56000786 56000747 56000339 56000559 56000308 56000727 56000741 56000792 56000750 56000825 56001012 56001641 56001131 56000818 56000327 56000661 56000255 56001021 56000533 56001111 56001689 56001152 56001141 56000756 56000585 56000427 56000261 56001570 56001535 56001139 56000317 56001184 56001530 56001558 56001334 56001437 56000883 56001445 56000186 56000308 56000315 56000327 56000339 56000458 56000559 56000718 56000727 56000741 56000747 56000750 56000786 56000792 56000824 56000825 56001062 56001235 56001635 56001641 56000568 56001153 OUS: Serial No 56000362 56000528 56000245 56000283 56000330 56000377 56000399 56000413 56000437 56000464 56000634 56000740 56000740 56000749 56000758 56000758 56000759 56000759 56000826 56001246 56001461 56001461 56000438 56000414 56000416 56000528 56000555 56000642 56000560 56000537 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0080-2019%22
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