Food, drugs, devices › Ortho Clinical Diagnostics
Device recall: VITROS 3600 Immunodiagnostic System Software Versions 3.3.3 and below Product Code: 6802783, Unique Identifier: 10758750
FDA enforcement event 85762 is a device recall by Ortho Clinical Diagnostics of Rochester, NY, initiated 20 May 2020 and classified Class II, with 5 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 93% of the 916 device enforcement events initiated in 2020 carry the same class.
Status: Terminated, terminated 16 Nov 2022. Initiation: voluntary: firm initiated. Ortho Clinical Diagnostics has 105 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Ortho Clinical Diagnostics, Rochester, NY.
Reason for recall
"Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances"
Distribution
"US Nationwide Distribution Foreign: Country AR AU BR CA CL CN CO DO FR ID IN JP KR MX MY NP PE PH SG TH TT VE VN"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2480-2020 | VITROS 3600 Immunodiagnostic System Software Versions 3.3.3 and below Product Code: 6802783, Unique Identifier: 10758750002979 | 779 (U.S.= 225;OUS= 554) | Class II | Terminated | 8 Jul 2020 |
| Z-2481-2020 | VITROS 3600 Immunodiagnostic System - Refurbished Product Code: 6802914 Unique Identifier: 10758750007103 | 27 ( U.S.= 0; OUS= 27) | Class II | Terminated | 8 Jul 2020 |
| Z-2482-2020 | VITROS 5600 Integrated System Software Versions 3.3.3 and below Product Code: 6802413 Unique Identifier: 10758750002740 | 2617 units (U.S.=1272; OUS=1344) | Class II | Terminated | 8 Jul 2020 |
| Z-2483-2020 | VITROS 5600 Integrated System - Refurbished Software Versions 3.3.3 and below Product Code: 6802915 Unique Identifier: 10758750007110 | 130 units (U.S.=57; OUS=73) | Class II | Terminated | 8 Jul 2020 |
| Z-2484-2020 | VITROS XT 7600 Integrated System Software Versions 3.5.1 and below Product Code:6844461 Unique Identifier: 10758750031610 | Total= 353 ( U.S.= 167; OUS 186) | Class II | Terminated | 8 Jul 2020 |
Context
Other enforcement events for Ortho Clinical Diagnostics
All 105 events for Ortho Clinical Diagnostics
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide Distribution Foreign: Country AR AU BR CA CL CN CO DO FR ID IN JP KR MX MY NP PE PH SG TH TT VE VN"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 16 Nov 2022. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.