Axis-Shield recalls HOMOCYSTEINE REAGENT Part Number FHRWR1000 due to potential under-recovery of sample results during testing. This affects professional medical devices used for hyperhomocysteinemia diagnosis.
There is a potential performance issue as detected by an under-recovery of sample results during routine testing.
Axis-Shield is recalling its HOMOCYSTEINE REAGENT (Part Number FHRWR1000) because tests may show under-recovered samples. This could lead to inaccurate diagnosis of hyperhomocysteinemia, a condition affecting blood protein levels.
The reagent may not properly recover samples during testing, leading to lower than expected results. This could cause misdiagnosis of hyperhomocysteinemia, a condition where blood has too much homocysteine.
Healthcare professionals using this reagent for medical testing are affected. Patients receiving diagnoses based on this test may be at risk of inaccurate results.
Check for the product name 'Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT' with Part Number FHRWR1000. The lot number 902924815 is associated with this recall.
Verify the Part Number FHRWR1000 and Lot Number 902924815 on the reagent packaging.
The recall is due to a potential under-recovery of sample results during routine testing, which could lead to inaccurate diagnosis of hyperhomocysteinemia.
The official recall notice does not specify a remedy or action for affected products.
The recall indicates a potential performance issue, but the reagent is still intended for professional medical use.
We’ve drafted a message you can send Axis-Shield to request your refund or repair — edit it as you like.
Subject: Recall Z-0744-2020 — Axis-Shield Axis-Shield Hello, I own a Axis-Shield that is covered by recall Z-0744-2020 from Axis-Shield. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
