Recall Z-0905-2022— Stanbio Laboratory, LP
Class II · Terminated
Class II FDA medical device recall by Stanbio Laboratory, LP, initiated 2022-03-16, terminated 2025-01-02. FDA's recall record names no specific 510(k) clearance for this event. Product: Separation Technology Creamatocrit Plus, Catalog Number: 100-146. 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).
- Recalling firm
- Stanbio Laboratory, LP
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2022-03-16
- Terminated
- 2025-01-02
- Firm location
- Boerne, TX, United States
Product description
Separation Technology Creamatocrit Plus, Catalog Number: 100-146
Reason for recall
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)
Data sourced from openFDA. This site is unofficial and independent of the FDA.