Boerne, TX, United States
Stanbio Laboratory, LP recalls
5 recalls recorded since 2018, most recently on 2 October 2023. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls5
Ongoing (FDA)1
Terminated or completed4
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 2 October 2023
- Reason
- 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 as the change in material that caused a pH shift in the coating solution resulting in precipitation during coating runs. The device defect can cause false negative results that may lead to a delay in treatment of patients with associated conditions such as diabetic ketoacidosis.
- Distribution
- Worldwide - US Nationwide distribution including in the states of AZ, RI, MO, UT, AK, LA, TX, OH, GA, MN, NY, CA, NJ, IL, WA, KS, MI, NC, PA, MA, CO, KY, NM, FL, MD, VA, IN, AL, SD, MS, WV, WI, ID, MT, WY and the countries of Canada and Singapore.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0490-2024
- STAT-Site M BHB Test Strips, used with STAT-SITE M Beta-HB Meter as an in vitro diagnostic for blood ketone values.
Terminated Class II Medical devices
- Recall started
- 16 March 2022
- Terminated
- 2 January 2025
- 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)
- Distribution
- US Nationwide Distribution CA, TX, OK, SD, IL, NV, MO, FL, WA, KY, WI, PA, NC, GA, MD, MN
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0905-2022
- Separation Technology Creamatocrit Plus, Catalog Number: 100-146
Terminated Class III Medical devices
- Recall started
- 12 July 2021
- Terminated
- 29 March 2022
- Reason
- Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.
- Distribution
- Worldwide distribution - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MI, MO, NC, NH, NJ, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, TN, TX, VA, VT, WA, WI, and WV. The countries of Australia, Canada, Chile, Federa
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2200-2021, Z-2201-2021, Z-2202-2021, Z-2199-2021, Z-2203-2021
- Beta-Hydroxybutyrate Reagent A - Enzyme (unlabeled). in vitro diagnostic reagent.
- Synchron CX/DX/LX Beta-Hydroxybutyrate . in vitro diagnostic reagent.
- Cardinal Health Beta-Hydroxybutyrate . in vitro diagnostic reagent.
- Beta-Hydroxybutyrate LiquiColor. in vitro diagnostic reagent.
- Cardinal Health Beta-Hydroxybutyrate LiquiColor for Synchron CX/LX/DX. in vitro diagnostic reagent.
Terminated Class II Medical devices
- Recall started
- 13 February 2018
- Terminated
- 27 September 2018
- Reason
- All patient serum samples yield a weakly positive test result.
- Distribution
- Worldwide Distribution - United States nationwide , Canada, Korea, Mexico, Trinidad
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1070-2018
- RaPET¿ RF Latex Reagent used as a component in the following kits: RaPET RF (1155-100, Control# 173201 expiry 2019-04-30) RF Latex (1156-001, Control# 172224 expiry 2019-12-31) RF Latex (1155L-100B, Control # 172701 ex
Terminated Class II Medical devices
- Recall started
- 8 February 2018
- Terminated
- 4 September 2020
- Reason
- The US prong (type A) adapter plate may crack, break, or detach and remain in the electrical outlet exposing live electrical contacts.
- Distribution
- Distribution was nationwide. There was military distribution and no government distribution. Foreign distribution was made to Bolivia, Malaysia, Mexico, Papua New Guinea, Paraguay, Philippines, and Suriname.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2926-2018
- Stanbio AC power adapter for the HemoPoint H2 meter, Model G3000 series. The firm name on the label for the HemoPoint H2 shows Manufactured by EKF-diagnostic GmbH, Germany.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.