Recall Z-0744-2020
Axis-Shield Diagnostics, Ltd. · initiated September 16, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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 hyperhomocysteinemia and homocystinuria. The device is intended for Professional use only.
Codes / lots: UDI: 05055845400183; Lot Number 902924815
Reason for recall
There is a potential performance issue as detected by an under-recovery of sample results during routine testing.
FDA-determined cause: Under Investigation by firm
Action taken
Urgent Medical Device Correction notification letters dated 9/16/19 were sent to customers. Necessary Actions Immediately discontinue use of the affected lots listed and switch to the alternate material lot(s) you may have available in your laboratory. Immediately destroy any remaining inventory of the affected lots listed according to your laboratory procedures. Complete and return the accompanying verification form Immediately order replacement material(s) if you do not have unaffected material available. Please retain this letter for your laboratory records.
Details
- Recall number
- Z-0744-2020
- Initiated
- September 16, 2019
- Product code
- LPS – Urinary Homocystine (Nonquantitative) Test System
- Quantity
- 740 total
- Distribution
- US Nationwide distribution in the states of CA, KY.
- Recalling firm
- Axis-Shield Diagnostics, Ltd., Dundee
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0742-2020 Class II | Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHBC100 -…There is a potential performance issue as detected by an under-recovery of sample results during routine… | 09/16/2019Open, Classified |
| Z-0743-2020 Class II | Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR100 -…There is a potential performance issue as detected by an under-recovery of sample results during routine… | 09/16/2019Open, Classified |