Axis-Shield recalls LS 2-Part HOMOCYSTEINE REAGENT (FHBC100) due to potential under-recovery of samples during testing. Affected lots: 902924530, 902925703. No remedy specified in recall notice.
There is a potential performance issue as detected by an under-recovery of sample results during routine testing.
Axis-Shield is recalling its LS 2-Part HOMOCYSTEINE REAGENT (Part Number FHBC100) because it may cause under-recovery of samples during testing. This could lead to inaccurate test results for hyperhomocysteinemia and homocystinuria. The recall affects specific lot numbers sold for professional use only.
The reagent may not properly recover samples during routine testing, leading to inaccurate test results. This could affect diagnosis and treatment decisions for conditions like hyperhomocysteinemia and homocystinuria. The issue is detected through under-recovery of sample results in testing procedures.
Healthcare professionals using this reagent for lab testing of hyperhomocysteinemia and homocystinuria. Patients receiving diagnoses based on this test may be at risk of inaccurate results.
Check for lot numbers 902924530 or 902925703 on the reagent packaging. The product is intended for professional laboratory use only and has a unique device identifier (UDI) of 05055845400282.
Look for lot numbers 902924530 or 902925703 on the reagent packaging.
The recall indicates a potential performance issue, but the reagent is still intended for professional use. Users should check the lot number and follow the recall instructions.
The recall does not specify a remedy, so no action is required beyond checking the lot number. Contact the manufacturer if you have the affected lot numbers.
Inaccurate test results could occur if the reagent under-recovers samples, potentially affecting diagnosis and treatment for hyperhomocysteinemia and homocystinuria.
We’ve drafted a message you can send Axis-Shield to request your refund or repair — edit it as you like.
Subject: Recall Z-0742-2020 — Axis-Shield Axis-Shield Hello, I own a Axis-Shield that is covered by recall Z-0742-2020 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.
