Stanbio Laboratory, LP
Stanbio Laboratory, LP has 5 FDA enforcement events on this register (9 product records) between 2018 and 2023: 5 device; the busiest year was 2018 with 2.
0% of its events are Class I; the most common class is Class II (4). 1 event is listed as ongoing; the recalling firm's address is in TX.
Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.
Enforcement events
| Initiated | Product (first record) | Type | Class | Records | Status |
|---|---|---|---|---|---|
| 2 Oct 2023 | STAT-Site M BHB Test Strips, used with STAT-SITE M Beta-HB Meter as an in vitro diagnostic for blood ketone values. | Device | Class II | 1 | Ongoing |
| 16 Mar 2022 | Separation Technology Creamatocrit Plus, Catalog Number: 100-146 | Device | Class II | 1 | Terminated |
| 12 Jul 2021 | Beta-Hydroxybutyrate LiquiColor. in vitro diagnostic reagent. | Device | Class III | 5 | Terminated |
| 13 Feb 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 expiry 2019-09-30 and Control # 173262 expiry 2019-12-31) Product Usage: RaPET¿ RF is intended for the… | Device | Class II | 1 | Terminated |
| 8 Feb 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. | Device | Class II | 1 | Terminated |
By type and class
Class I: 0% of this firm's events; 18% of all events on the register.
Events by year
Questions and answers
How many FDA recalls has Stanbio Laboratory, LP had?
5 enforcement events (9 product records) on this register, 2018–2023: 5 device.
Are any Stanbio Laboratory, LP recalls ongoing?
1 event is listed as ongoing in the current openFDA export.
What class are Stanbio Laboratory, LP recalls?
4 Class II, 1 Class III. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.
Where does this data come from?
openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.
Provenance
Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.