Stanbio Laboratory recalls
2 official recalls and safety alerts involving Stanbio Laboratory since 2022-04, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Stanbio Laboratory or the relevant agency.
- 2023-12-13
USStanbio Laboratory, LP recalls STAT-Site M BHB Test Strips, used with STAT-SITE M Beta-HB Meter as an in vitro diagnostic for blood ketone values.
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 →- 2022-04-20
- US
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…
FDA · DeviceStanbio Laboratory, LPUS Nationwide Distribution CA, TX, OK, SD, IL, NV, MO, FL, WA, KY, WI, PA, NC,…Official notice →