Stanbio Laboratory, LP recalls Separation Technology Creamatocrit Plus, Catalog Number: 100-146
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…
Read the official notice →- Date
- 2022-04-20
- Country
- United States
- Brand
- Stanbio Laboratory
- Product
- Separation Technology Creamatocrit Plus, Catalog Number: 100-146
- Classification
- Class II
- Units
- US Nationwide Distribution CA, TX, OK, SD, IL, NV, MO, FL, WA, KY, WI, PA, NC,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Stanbio Laboratory recalls
- 2023-12-13
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Deterioration in the stability of the Test Strips results in diminished low-range detection capability and inability to meet linearity performance claims. The root cause of the stability deterioration in is identified…
FDA · DeviceStanbio Laboratory, LPWorldwide - US Nationwide distribution including in the states of AZ, RI, MO,…Official notice →
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Product was distributed without being sterilized.
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Volcano Corp recalls IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102
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