FDA Device recall Z-1556-2013
VITROS Chemistry Products-HCY Reagent packaged in a kit carton
- FDA Device
- Class II
- terminated
- Published 2013-06-26
On 2013-06-26 the FDA classified a Class II recall of VITROS Chemistry Products-HCY Reagent packaged in a kit carton by Ortho Clinical Diagnostics, citing the firm is recalling the specific lot due to lower than expected results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1556-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-04-01 |
| Published | 2013-06-26 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | US |
Product
VITROS Chemistry Products-HCY Reagent packaged in a kit carton. Catalog# 6802002. Used to quantitatively measure total homocysteine (HCY) concentration in human serum and plasma.
Reason
The firm is recalling the specific lot due to lower than expected results.
Identifiers
| code_info | Lot # 1529-17-2636, expiration date 12 June 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-1556-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.