FDA Device recall Z-1521-2015
Software Version 2.8 & Below on VITROS 5,1 FS Chemistry Systems, Catalog Number 6801375, Global Trade Item Number 10758750001132, and VITRO…
- FDA Device
- Class II
- terminated
- Published 2015-05-06
On 2015-05-06 the FDA classified a Class II recall of Software Version 2.8 & Below on VITROS 5,1 FS Chemistry Systems, Catalog Number 6801375, Global Trade Item Number 10758750001132, and VITRO… by Ortho Clinical Diagnostics, citing software Anomaly; It is possible for the device to process samples with a cartridge other than the intended cartridge, potentially leading to erroneous patient results. If this an….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1521-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-03-10 |
| Published | 2015-05-06 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | PR |
Product
Software Version 2.8 & Below on VITROS 5,1 FS Chemistry Systems, Catalog Number 6801375, Global Trade Item Number 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number 6801890, Global Trade Item Number 10758750001644; IVD. Intended for use in the in vitro quantitative, semi quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides and VITROS Chemistry Products MicroTip Reagents.
Reason
Software Anomaly; It is possible for the device to process samples with a cartridge other than the intended cartridge, potentially leading to erroneous patient results. If this anomaly occurred previously, an indication would be a series of results that were similar across multiple samples (i.e., results could be believable or outside of the Reportable Range for the intended assay).
Identifiers
| code_info | Software Version 2.8 & Below; VITROS 5,1 FS Chemistry System Serial Numbers 34000119 - 34002323; VITROS 5,1 Refurbished…Software Version 2.8 & Below; VITROS 5,1 FS Chemistry System Serial Numbers 34000119 - 34002323; VITROS 5,1 Refurbished: Serial Numbers - Domestic S/Ns: 34000133, 34000193, 34000197, 34000212, 34000285, 34000316, 34000318, 34000337, 34000360, 34000420, 34000451, 34000464, 34000478, 34000495, 34000497, 34000529, 34000538, 34000552, 34000557, 34000590, 34000596, 34000601, 34000631, 34000642, 34000761, 34000799, 34000805, 34000833, 34000851, 34000893, 34000946, 34000947, 34001006, 34001172, 34001218, 34001240, 34001243, 34001248, 34001251, 34001274, 34001297, 34001311, 34001317, 34001345, 34001378, 34001379, 34001389, 34001390, 34001396, 34001422, 34001472, 34001504, 34001569, 34001572, 34001589, 34001610, 34001612, 34001626, 34001633, 34001668, 34001755, 34001809, 34001840, 34001850, 34001875, 34001897; Foreign S/Ns: 34000123, 34000143, 34000191, 34000215, 34000219, 34000235, 34000251, 34000256, 34000260, 34000261, 34000319, 34000331, 34000380, 34000382, 34000406, 34000408, 34000412, 340 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1521-2015%22
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