FDA Device recall Z-1946-2015
Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT
- FDA Device
- Class II
- terminated
- Published 2015-07-08
On 2015-07-08 the FDA classified a Class II recall of Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT by Axis Shield Diagnostics, citing deterioration in performance of the Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT resulting in under recovery.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1946-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-03-20 |
| Published | 2015-07-08 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Axis Shield Diagnostics |
| Distribution | US |
Product
Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT; 100 test format, 1000 test format, and 200 test format; and Private Label: (Distributed by BECKMAN COULTER, for professional use only, on the BECKMAN COULTER AU platforms (AU400, AU480, AU680 and AU5800)) Product Usage: For in-vitro quantitative determination of total homocysteine in human plasma or serum.
Reason
Deterioration in performance of the Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT resulting in under recovery.
Identifiers
| code_info | Part Number/Lot Number: FHBC100/802899574; FHRWR100/802899249; FHRWR1000/802899248; FHRWR200/802899989; FHRWR200/802899250; FHRWCN1/802900104 |
|---|
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-1946-2015%22
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