Ortho-Clinical recalls VITROS VersaTips (Catalog 6801715) due to potential 16% sample volume reduction causing inaccurate blood tests. Affected units may lead to incorrect drug dosing or false positive/negative results for infectious diseases.
The lot has a shape deformity which may lead to a 16% reduction in the volume of the sample or reagent dispensed. In cases where the error is not detected and the affected results are not suppressed, clinical impact may include reduced drug dosage, or false positive or false negative results for bloodborne infectious disease assays when sample results are close to the cut-off value.
Ortho-Clinical is recalling VITROS VersaTips (1000 tips per box) because some units may dispense 16% less sample volume. This could cause incorrect drug dosing or false test results for bloodborne infections if not caught.
The VersaTips have a shape deformity that reduces sample volume by up to 16%. If the error isn't noticed and the test results aren't suppressed, it could lead to incorrect drug dosing or false positive/negative results for bloodborne infections when test results are near the cutoff threshold.
Users of VITROS VersaTips for blood testing are affected. Those performing critical blood tests for infectious diseases or medication dosing are at higher risk if the error goes undetected.
Check for the catalog number 6801715 on the VersaTip box. The lot number 1039734 is also associated with this recall.
Look for the catalog number 6801715 and lot number 1039734 on the box.
The VersaTips have a shape deformity that may reduce sample volume by up to 16%, potentially causing inaccurate test results.
The recall addresses potential inaccurate test results, not direct injury. Serious injury is not mentioned in the recall.
Check for the catalog number 6801715 and lot number 1039734 on the box.
We’ve drafted a message you can send Ortho-Clinical to request your refund or repair — edit it as you like.
Subject: Recall Z-0735-2022 — Ortho-Clinical Ortho-Clinical Hello, I own a Ortho-Clinical that is covered by recall Z-0735-2022 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.
