FDA Device recall Z-0557-2014
VITROS Anti-HBs Calibrators & VITROS Anti-HBs Reagent Packs
- FDA Device
- Class II
- terminated
- Published 2014-01-01
On 2014-01-01 the FDA classified a Class II recall of VITROS Anti-HBs Calibrators & VITROS Anti-HBs Reagent Packs by Ortho Clinical Diagnostics, citing ortho Clinical Diagnostics issued a Product Correction Notification for VITROS Immunodiagnostic Products Anti-HBs Calibrators and Anti-HBs Quantitative Reagent Packs due to false….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0557-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-10-25 |
| Published | 2014-01-01 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | US |
Product
VITROS Anti-HBs Calibrators & VITROS Anti-HBs Reagent Packs
Reason
Ortho Clinical Diagnostics issued a Product Correction Notification for VITROS Immunodiagnostic Products Anti-HBs Calibrators and Anti-HBs Quantitative Reagent Packs due to false positive results.
Identifiers
| code_info | Product Code 1) 6801926, 2) 6801925, 3) 6802452 Lot numbers: 1) 6700, 2) 6731, 3) 6830 Expiry Dates: 1) 21 May 2013, 2) 24 July 2013, 3) 11 Sept 2013 |
|---|
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-0557-2014%22
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