FDA Device recall Z-0313-2017
VITROS Immunodiagnostic Products HBsAg Controls, Product Code 6800598 For in vitro diagnostic use only
- FDA Device
- Class III
- terminated
- Published 2016-11-02
On 2016-11-02 the FDA classified a Class III recall of VITROS Immunodiagnostic Products HBsAg Controls, Product Code 6800598 For in vitro diagnostic use only by Ortho Clinical Diagnostics, citing the signal/cutoff (s/c) results may increase throughout the open-reconstituted timeframe of the allowed 5 days. Increased results may occur on both the negative and positive Contr….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0313-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-06-22 |
| Published | 2016-11-02 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | US |
Product
VITROS Immunodiagnostic Products HBsAg Controls, Product Code 6800598 For in vitro diagnostic use only. For use in monitoring the performance of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System when used for the in vitro qualitative detection of Hepatitis B Surface Antigen (HBsAg) in human serum and plasma (heparin, EDTA or citrate). The performance of the VITROS Immunodiagnostic Products HBsAg Controls has not been established with any other HBsAg assay.
Reason
The signal/cutoff (s/c) results may increase throughout the open-reconstituted timeframe of the allowed 5 days. Increased results may occur on both the negative and positive Controls. The positive Control, although showing elevated results, was still within acceptable performance.
Identifiers
| code_info | Product Code 6800598-Lot #'s: 1) 0860, 2) 0870, 3) 0880, 4) 0890, 5) 0908 Expiration: 1) 29-MAR-17, 2) 12-JUN-17, 3) 02-JUL-17, 4) 23-NOV-17, 5) 29-JAN-18 |
|---|
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-0313-2017%22
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