FDA Device recall Z-2481-2020
VITROS 3600 Immunodiagnostic System - Refurbished Product Code: 6802914 Unique Identifier: 10758750007103
- FDA Device
- Class II
- terminated
- Published 2020-07-08
On 2020-07-08 the FDA classified a Class II recall of VITROS 3600 Immunodiagnostic System - Refurbished Product Code: 6802914 Unique Identifier: 10758750007103 by Ortho Clinical Diagnostics, citing modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2481-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-05-20 |
| Published | 2020-07-08 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | US |
Product
VITROS 3600 Immunodiagnostic System - Refurbished Product Code: 6802914 Unique Identifier: 10758750007103
Reason
Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances
Identifiers
| code_info | Affected Serial Number : 36000192 36000396 36000430 36000431 36000446 36000468 36000504 36000517 36000577 360…Affected Serial Number : 36000192 36000396 36000430 36000431 36000446 36000468 36000504 36000517 36000577 36000580 36000585 36000631 36000647 36000366 36000267 36000386 36000404 36000420 36000562 36000614 36000575 36000589 36000480 36000582 36000687 36000492 36001042 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2481-2020%22
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