CLASS II Device recall · Reported 8 Jul 2015 · 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 20 Mar 2015 and the FDA has classified it as Class II.
Check your package
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-1946-2015
- FDA event ID
- 70992
- Recalling firm
- Axis-Shield Diagnostics, Dundee
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Mar 2015
- FDA classified
- 2 Jul 2015
- Reported
- 8 Jul 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 20 Mar 2015 | Recall initiated by company | |
| 2 Jul 2015 | Classified by FDA | +104 days |
| 8 Jul 2015 | Published 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
Deterioration in performance of the Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT resulting in under recovery.
Product as listed by the FDA
Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT; 100 test format, 1000 test format, and 200 test format; and Private Label: (Distributed by BECKMAN COULTER, for professional use only, on the BECKMAN COULTER AU platforms (AU400, AU480, AU680 and AU5800)) Product Usage: For in-vitro quantitative determination of total homocysteine in human plasma or serum.
Where it was distributed
Worldwide Distribution - US Nationwide in the states of: KY, WA, CA, and PA and the country of Germany.
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 20 Mar 2015. The recall is Class II and its status is Terminated. Recall number Z-1946-2015.
Why was it recalled?
Deterioration in performance of the Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT resulting in under recovery.
Which lots are affected?
Part Number/Lot Number: FHBC100/802899574; FHRWR100/802899249; FHRWR1000/802899248; FHRWR200/802899989; FHRWR200/802899250; FHRWCN1/802900104
Where was it sold?
Worldwide Distribution - US Nationwide in the states of: KY, WA, CA, and PA and the country of Germany.
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| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent recalled | Axis-Shield Diagnostics | Other | Nationwide |
| Device | CLASS II | Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent recalled | Axis-Shield Diagnostics | Other | Nationwide |
| Device | CLASS II | Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent recalled | Axis-Shield Diagnostics | Other | Nationwide |
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