Drug recall
Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHBC100 - Product Usage: The device…
FDA recall event 84043 · Class II · Axis-Shield Diagnostics, Ltd.
Key facts
| Event ID | 84043 |
|---|---|
| Recall numbers | Z-0742-2020, Z-0743-2020, Z-0744-2020 |
| Recalling firm | Axis-Shield Diagnostics, Ltd. |
| Product type | Devices |
| Products | Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHBC100 - Product Usage: The device can assist in the diagnosis and treatment of patients suspected of having…, Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR1000 - Product Usage: The device can assist in the diagnosis and treatment of patients suspected of having…, Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR100 - Product Usage: The device can assist in the diagnosis and treatment of patients suspected of having… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | There is a potential performance issue as detected by an under-recovery of sample results during routine testing. |
| Initiation date | Sep 16, 2019 |
| Report date | Jan 1, 2020 |
| City | Dundee |
| Country | United Kingdom |
| FEI number | 3002808140 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: