Axis-Shield recalls HOMOCYSTEINE REAGENT Part Number FHRWR100 due to potential sample under-recovery during testing. This affects professional medical devices used for diagnosing hyperhomocysteinemia.
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 FHRWR100) because it may cause inaccurate test results due to under-recovery of samples. This could lead to incorrect diagnoses of hyperhomocysteinemia or homocystinuria in patients.
The reagent may not properly recover samples during testing, leading to inaccurate test results. This could cause misdiagnosis of hyperhomocysteinemia or homocystinuria, conditions that require precise measurement.
Healthcare professionals using this reagent for medical testing are affected. Patients receiving diagnoses based on this reagent may be at risk of incorrect results.
Check for the Part Number FHRWR100 on the reagent container. The product was sold with Lot Number 902924526 and UDI 05055845400169. It is intended for professional medical use only.
Look for the Part Number FHRWR100 and Lot Number 902924526 on the reagent container.
The recall is due to potential under-recovery of samples, not safety risks. The reagent is intended for professional medical use only.
Patients receiving diagnoses based on this reagent may have inaccurate results. They should consult their healthcare provider for alternative testing.
Check the Part Number FHRWR100 and Lot Number 902924526 on the reagent container. The product was sold with UDI 05055845400169.
We’ve drafted a message you can send Axis-Shield to request your refund or repair — edit it as you like.
Subject: Recall Z-0743-2020 — Axis-Shield Axis-Shield Hello, I own a Axis-Shield that is covered by recall Z-0743-2020 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.
