Haemonetics recalls TEG 5000 Functional Fibrinogen Reagent (Item 07-034) due to potential misdiagnosis from outdated blood reference ranges. All lots affected.
Due to a shift in the citrated blood reference range for a normal population, the ranges stated in the IFU are changing. If the clinician relies solely on affected results in comparison to the normal donor reference range, it could lead to misdiagnosis and incorrect treatment or failure to treat.
Haemonetics is recalling its TEG 5000 Functional Fibrinogen Reagent (Item 07-034) because outdated blood reference ranges could lead to misdiagnosis and incorrect treatment. This affects all units produced.
The reagent's blood reference ranges are outdated compared to current normal population standards. If clinicians rely on these outdated ranges for diagnosis, it could cause misdiagnosis and incorrect treatment decisions.
Healthcare providers using this reagent for blood testing are affected. Patients receiving treatment based on this reagent may be at risk of incorrect diagnoses.
Check for the product name 'TEG 5000 Functional Fibrinogen Reagent' with item number 07-034. All lots are affected and no specific model or date range is mentioned.
Verify the item number on the reagent packaging to confirm it is affected (Item 07-034).
The recall states that all lots are affected, but the product itself is not unsafe—only outdated reference ranges could lead to misdiagnosis.
The recall does not specify a stop-use action; the product can still be used but with awareness of potential misdiagnosis risks.
Look for the item number 07-034 on the reagent packaging. All lots are affected, so no specific date or model range is provided.
We’ve drafted a message you can send Haemonetics to request your refund or repair — edit it as you like.
Subject: Recall Z-1310-2022 — Haemonetics Haemonetics Hello, I own a Haemonetics that is covered by recall Z-1310-2022 from Haemonetics. 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.
