Separation Technology Creamatocrit Plus recall
Separation Technology Creamatocrit Plus, Catalog Number: 100-146
Why was Separation Technology Creamatocrit Plus recalled?
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)
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Sold between 2019 and 2021
- Product
- Separation Technology Creamatocrit Plus, Catalog Number: 100-146
- Recalling firm
- Stanbio Laboratory, LP
- Quantity
- 50
- Distribution
- US Nationwide Distribution CA, TX, OK, SD, IL, NV, MO, FL, WA, KY, WI, PA, NC, GA, MD, MN
- Recall date
- April 20, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)