Stanbio recalls Creamatocrit Plus breast milk analyzers (2019-2021) due to unvalidated performance as an IVD, risking suboptimal infant nutrition. Affected users should contact for remedy.
The device was being marketed as an IVD without a 510(k). Therefore, performance characteristics of these breast milk analyzers have not been adequately validated. An erroneous result could lead to sub-optimal nutrition supplementation for patients (infants)
Stanbio is recalling its Creamatocrit Plus breast milk analyzers because they were sold without proper regulatory approval. This could lead to inaccurate results and improper infant nutrition. Affected users should contact Stanbio for instructions.
The device was marketed as an IVD (in vitro diagnostic) without proper regulatory approval. This means its performance characteristics weren't validated, so results might be inaccurate. Inaccurate results could lead to improper infant nutrition.
Parents or caregivers using the Creamatocrit Plus for breast milk analysis in infants are most at risk. The device was sold between 2019 and 2021.
Check for the catalog number 100-146 on the device. The Creamatocrit Plus was sold between 2019 and 2021.
Reach out to Stanbio Laboratory for instructions on how to handle the device.
The device was sold without proper regulatory approval, so results may be inaccurate. It is not recommended for use without consulting Stanbio.
The Creamatocrit Plus was sold between 2019 and 2021.
Look for the catalog number 100-146 on the device. It was sold between 2019 and 2021.
We’ve drafted a message you can send Stanbio to request your refund or repair — edit it as you like.
Subject: Recall Z-0905-2022 — Stanbio Stanbio Hello, I own a Stanbio that is covered by recall Z-0905-2022 from Stanbio. 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.
