Ortho-Clinical recalls VITROS Folate Reagent Pack 1/2 due to fibrinogen precipitation causing delayed test results. Affected lots include 3380-3480.
It was confirmed that fibrinogen in patient plasma samples precipitates out of solution upon the addition of folate stabilizer reagent as part of the pre-treatment process causing the increase in "TM5-4MB" condition codes which lead to a delay of results.
Ortho-Clinical is recalling VITROS Folate Reagent Pack 1/2 because fibrinogen in patient samples can precipitate when the reagent is added, leading to delayed test results. This affects lab tests and could cause inaccurate health assessments if not corrected.
Fibrinogen in patient plasma samples precipitates when the folate stabilizer reagent is added during pre-treatment. This causes an increase in "TM5-4MB" condition codes, which delays test results without causing physical injury.
Lab users who handle the VITROS Folate Reagent Pack 1/2 are affected. Those using the product for blood tests may experience delayed results but no immediate harm.
Check for model number 1513266 on the reagent pack. Affected lots are 3380, 3390, 3400, 3410, 3422, 3430, 3440, 3450, 3461, 3471, and 3480.
Identify the lot number on the VITROS Folate Reagent Pack 1/2 to see if it is affected (3380-3480).
The recall is due to fibrinogen in patient plasma samples precipitating when the folate stabilizer reagent is added, causing delayed test results.
Check the lot number on the reagent pack. If it is in the affected lots (3380-3480), contact Ortho-Clinical for instructions.
No, the hazard only causes delayed test results, not physical injury.
We’ve drafted a message you can send Ortho-Clinical to request your refund or repair — edit it as you like.
Subject: Recall Z-2580-2024 — Ortho-Clinical Ortho-Clinical Hello, I own a Ortho-Clinical that is covered by recall Z-2580-2024 from Ortho-Clinical. 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.
