CLASS II ONGOING Device recall · Reported 1 Jan 2020 · FDA Enforcement Report

Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent recalled

Axis-Shield Diagnostics is recalling Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent, distributed nationwide in the US. The recall was initiated on 16 Sep 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI: 05055845400169; Lot Number 902924526
Quantity recalled740 total

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-0743-2020
FDA event ID
84043
Recalling firm
Axis-Shield Diagnostics, Dundee
Classification
Class II
Status
Ongoing
Recall initiated
16 Sep 2019
FDA classified
26 Dec 2019
Reported
1 Jan 2020
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Other Reasons

Timeline

16 Sep 2019Recall initiated by company
26 Dec 2019Classified by FDA+101 days
1 Jan 2020Published in enforcement report+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

There is a potential performance issue as detected by an under-recovery of sample results during routine testing.

Product as listed by the FDA

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 hyperhomocysteinemia and homocystinuria. The device is intended for Professional use only.

Where it was distributed

US Nationwide distribution in the states of CA, KY.

Nationwide CaliforniaKentucky

Questions about this recall

Is Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent recalled?

Yes. Axis-Shield Diagnostics recalled Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent on 16 Sep 2019. The recall is Class II and its status is Ongoing. Recall number Z-0743-2020.

Why was it recalled?

There is a potential performance issue as detected by an under-recovery of sample results during routine testing.

Which lots are affected?

UDI: 05055845400169; Lot Number 902924526

Where was it sold?

US Nationwide distribution in the states of CA, KY.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Axis-Shield Diagnostics

All 4
ReportedClassRecallCompanyReasonWhere
DeviceCLASS IIAxis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent recalledAxis-Shield DiagnosticsOtherNationwide
DeviceCLASS IIAxis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent recalledAxis-Shield DiagnosticsOtherNationwide
DeviceCLASS IIAxis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent recalledAxis-Shield DiagnosticsOtherNationwide

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