Ortho-Clinical recalls VITROS VersaTips from specific lots due to deformities that may cause up to 16% sample measurement errors in lab tests. Affected lots include VITROS 250, 350, ECi, 5,1 FS, 3600, 4600, 5600, and XT7600 models.
A deformity affecting a specific lot of VITROS¿ Chemistry Products VersaTips. Deformed VersaTips results may be biased by up to +/-16% for both immunometric and competitive assays.
Ortho-Clinical is recalling VITROS VersaTips used in lab testing because some versions have deformities that can cause sample measurement errors up to 16%. This affects lab equipment accuracy and could lead to incorrect test results if not fixed.
Deformed VersaTips can cause sample measurement errors of up to 16% in immunometric and competitive assays. This means lab results might be inaccurate, potentially leading to incorrect diagnoses or treatment decisions.
Lab users with VITROS 250, 350, ECi, 5,1 FS, 3600, 4600, 5600, or XT7600 models who use the VersaTips for sample dispensing. The risk is highest for labs that rely on precise measurements for critical tests.
Check if your VITROS 250, 350, ECi, 5,1 FS, 3600, 4600, 5600, or XT7600 models have lot number 413420. The VersaTips are used to dispense samples for MicroSlide and MicroWell assays.
Look for lot number 413420 on the VersaTips packaging or label.
Deformed VersaTips in lot 413420 can cause sample measurement errors up to 16% in lab tests, potentially leading to inaccurate results.
VITROS 250, 350, ECi, 5,1 FS, 3600, 4600, 5600, and XT7600 models with lot number 413420.
No, but you should check if your VersaTips have lot number 413420 and replace them if needed to avoid measurement errors.
We’ve drafted a message you can send Ortho-Clinical to request your refund or repair — edit it as you like.
Subject: Recall Z-1136-2021 — Ortho-Clinical Ortho-Clinical Hello, I own a Ortho-Clinical that is covered by recall Z-1136-2021 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.
