Separation Technology Creamatocrit Plus, Catalog Number: 100-146
Reported: April 20, 2022 Initiated: March 16, 2022 #Z-0905-2022
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)
Details
- Recalling Firm
- Stanbio Laboratory, LP
- Units Affected
- 50
- Distribution
- US Nationwide Distribution CA, TX, OK, SD, IL, NV, MO, FL, WA, KY, WI, PA, NC, GA, MD, MN
- Location
- Boerne, TX
Frequently Asked Questions
What product was recalled? ▼
Separation Technology Creamatocrit Plus, Catalog Number: 100-146. Recalled by Stanbio Laboratory, LP. Units affected: 50.
Why was this product 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)
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 20, 2022. Severity: Moderate. Recall number: Z-0905-2022.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11