Recall Z-0905-2022 ยท QEI Breast Milk Macronutrients Test System
Stanbio Laboratory, LP
Separation Technology Creamatocrit Plus, Catalog Number: 100-146
| Date | Mar 16, 2022 |
| Status | Terminated |
| Reason | 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) |
| Root cause | No Marketing Application |
| Action | On 03/16/22, recall notices were mailed to customers who were asked to take the following actions: Stop using the affected device while you review the new Research Use Only labeling included with this letter. If you are using the affected device for research use only, then apply/use the new labeling. If you are using the affected human breast milk analyzer to provide information relating to the nutritional management of infants, then destroy the product in accordance with local regulations. If the affected product was further distributed or forwarded elsewhere, then forward this recall notic |
| Quantity | 50 |
| Distribution | US Nationwide Distribution CA, TX, OK, SD, IL, NV, MO, FL, WA, KY, WI, PA, NC, GA, MD, MN |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.