Recall Z-0744-2020 ยท LPS Urinary Homocystine (Nonquantitative) Test System
Axis-Shield Diagnostics, Ltd.
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.
| Date | Sep 16, 2019 |
| Status | Open, Classified |
| Reason | There is a potential performance issue as detected by an under-recovery of sample results during routine testing. |
| Root cause | Under Investigation by firm |
| Action | 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. |
| Quantity | 740 total |
| Distribution | US Nationwide distribution in the states of CA, KY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083222 | AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100 Axis-Shield Diagnostics, Ltd., Jul 31, 2009 |