Axis-Shield Liquid Stable — Class II medical device recall Z-1946-2015
Terminated recall by Axis-Shield Diagnostics, Ltd., reported 2015-07-08, distributed nationwide. Deterioration in performance of the Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT resulting in under recovery
| Recall number | Z-1946-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Axis-Shield Diagnostics, Ltd., Dundee, United Kingdom |
| Recall initiated | 2015-03-20 |
| Classified | 2015-07-02 |
| Reported by FDA | 2015-07-08 |
| Terminated | 2015-10-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | DE |
| Lot numbers | FHBC100/802899574, FHRWCN1/802900104, FHRWR100/802899249, FHRWR1000/802899248, FHRWR200/802899250, FHRWR200/802899989 |
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 for recall
Deterioration in performance of the Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT resulting in under recovery.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1946-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.