Z-0744-2020Class II

Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR1000 -

Name: Z-0744-2020 Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR1000 -
Creator: Axis-Shield Diagnostics, Ltd.
Published: 2019-09-16
License: https://open.fda.gov/license/

Axis-Shield Diagnostics, Ltd. / initiated 2019-09-16 / Open, Classified

FDA source

Axis-Shield Diagnostics, Ltd. began a recall of Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR1000 - Product Usage: The device can assist in the diagnosis and treatment of... on 2019-09-16. FDA classified it as Class II and gives the reason as "There is a potential performance issue as detected by an under-recovery of sample results during routine testing". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0744-2020
Classification: Class II
Status: Open, Classified
Initiated: 2019-09-16
Posted: 2019-12-26
Recalling firm: Axis-Shield Diagnostics, Ltd.
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.
Product code: LPS Urinary Homocystine (Nonquantitative) Test System
Reason for recall: There is a potential performance issue as detected by an under-recovery of sample results during routine testing.
FDA 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 in commerce: 740 total
Distribution: US Nationwide distribution in the states of CA, KY.
Product codes and lots: UDI: 05055845400183; Lot Number 902924815

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0744-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0742-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-01-01	2019-12-26
Z-0743-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-01-01	2019-12-26
Z-0744-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-01-01	2019-12-26

Product code LPS

K083222Class IIAxis-Shield Liquid Stable (Ls) 2-Part Homocysteine Reagent, Model Fhrk100Axis-Shield Diagnostics, Ltd. / cleared 2009-07-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)