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.

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

Recall #: Z-0744-2020
Affected scope: 740 total
Initiated: September 16, 2019

Compiled from official public sources by the publisher. · Updated September 2026

Axis-Shield Diagnostics, Ltd. recalled Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR1000 - Produ… - a moderate-severity action.

Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR1000 - Produ… was recalled by Axis-Shield Diagnostics, Ltd. in January 1, 2020. Reason: There is a potential performance issue as detected by an under-recovery of sample results during routine test…. Check the official notice for the remedy. Verify recall #Z-0744-2020 with the FDA Devices before acting.

The recall

Axis-Shield Diagnostics, Ltd. issued this moderate-severity FDA Devices recall-There is a potential performance issue as detected by an under-recovery of sample results during routine test….

Moderate
severity level: Class II
classification: January 1, 2020
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-0744-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

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.

Reason for recall

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

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Ongoing
Recall number	Z-0744-2020
Date reported	January 1, 2020
Date initiated	September 16, 2019
Recalling firm	Axis-Shield Diagnostics, Ltd.
Firm location	Dundee
Affected scope	740 total
Distribution	US Nationwide distribution in the states of CA, KY.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-0744-2020) and product description against the item you own. Search the archive
Confirm the current status with FDA Devices before acting, recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

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

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on January 1, 2020. Severity: Moderate. Recall number: Z-0744-2020.

Where was the recalled product distributed? ▼

Distribution: US Nationwide distribution in the states of CA, KY..

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Similar severity · nearest report date

Same archive severity grade (Moderate), closest by report date among other firms and states.

Estriol [(16a, 17B)-Estra-1,3,5(10)-trien… 2020-01-01 Wild Harvest Organic Unbleached All Purpo… 2020-01-01 White Castle Sliders - Cheese Sliders - C… 2020-01-01 White Castle Sliders - The Original Slide… 2020-01-01

Similar Medical Devices · nearest report date

Same product category, closest by report date among other firms and states (deduped against the severity set).

Babi.Plus 12.5 cm H2O Pressure Relief Man… 2020-01-01 Babi.Plus Bubble PAP Valve with 12.5 cm H… 2020-01-01 Babi.Plus 12.5 cm H2O Pressure Relief Man… 2020-01-01 VNS Therapy, SenTiva, Model # 1000, (01)0… 2020-01-01

Compare this recall with GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VS… → · All Medical Devices recalls

This recall: FDA Devices, reported January 1, 2020. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026