Ortho-Clinical recalls VITROS High Sample Diluent A Reagent Pack Lot 2190 due to potential inaccurate TSH test results. Affected users should contact the manufacturer for details.
Lower than expected results for VITROS¿ Immunodiagnostic Products TSH Reagent Pack when diluted with VITROS¿ Immunodiagnostic Products High Sample Diluent A Reagent Pack Lot 2190.
Ortho-Clinical is recalling VIT:ROS High Sample Diluent A Reagent Pack Lot 2190 because it can cause lower than expected results when used with TSH reagent packs. This may lead to incorrect thyroid function test results.
The recalled reagent pack can produce lower than expected results when diluted with the TSH reagent pack. This may cause inaccurate thyroid function test results, potentially leading to incorrect health decisions.
Users of VITROS immunodiagnostic test kits who purchased the recalled reagent pack Lot 2190 are affected. Patients relying on thyroid function tests are most at risk.
Check for the lot number 2190 on the VITROS High Sample Diluent A Reagent Pack. The product code is 8430373 (10758750004898).
Verify the lot number on the VITROS High Sample Diluent A Reagent Pack is 2190.
The recalled reagent pack can cause lower than expected results when used with TSH reagent packs, potentially leading to inaccurate thyroid function test results.
The recall record does not specify a remedy, so contact Ortho-Clinical Diagnostics for further instructions.
The recall does not mention any risk of serious injury; the hazard is related to inaccurate test results.
We’ve drafted a message you can send Ortho-Clinical to request your refund or repair — edit it as you like.
Subject: Recall Z-0503-2022 — Ortho-Clinical Ortho-Clinical Hello, I own a Ortho-Clinical that is covered by recall Z-0503-2022 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.
