# P000014: Vitros Immunodiagnostic Products:Anti-HBS Reagent Pack/Anti-HBS Calibrators

- Pathway: PMA
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: Sep 29, 2000 after 211 days
- Product code: SEI (Qualitative And Quantitative Hepatitis B Virus Antibody Assays)
- Device class: 2
- Regulation: 21 CFR 866.3173
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Nov 27, 2023 · Class II · Z-0772-2024: Affected lots may experience increased calibration failures or an increase in falsely elevated results.
- Oct 25, 2013 · Class II · Z-0557-2014: 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.

Source page: https://510kreport.com/device/P000014
Methodology: https://510kreport.com/methodology