Stanbio Laboratory, LP
Complete recall history across all FDA and CPSC categories — 9 total recalls
Stanbio Laboratory, LP appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (9)
FDA medical device enforcement actions by Stanbio Laboratory, LP
| Date | Product | Reason | Class |
|---|---|---|---|
| Oct 2, 2023 | STAT-Site M BHB Test Strips, used with STAT-SITE M Beta-HB Meter as an in vit... | Deterioration in the stability of the Test Strips results in diminished low-r... | Class II |
| Mar 16, 2022 | Separation Technology Creamatocrit Plus, Catalog Number: 100-146 | The device was being marketed as an IVD without a 510(k). Therefore, performa... | Class II |
| Jul 12, 2021 | Cardinal Health Beta-Hydroxybutyrate LiquiColor for Synchron CX/LX/DX. in vi... | Deterioration in the stability of the reagents which has resulted in lower th... | Class III |
| Jul 12, 2021 | Beta-Hydroxybutyrate LiquiColor. in vitro diagnostic reagent. | Deterioration in the stability of the reagents which has resulted in lower th... | Class III |
| Jul 12, 2021 | Cardinal Health Beta-Hydroxybutyrate . in vitro diagnostic reagent. | Deterioration in the stability of the reagents which has resulted in lower th... | Class III |
| Jul 12, 2021 | Synchron CX/DX/LX Beta-Hydroxybutyrate . in vitro diagnostic reagent. | Deterioration in the stability of the reagents which has resulted in lower th... | Class III |
| Jul 12, 2021 | Beta-Hydroxybutyrate Reagent A - Enzyme (unlabeled). in vitro diagnostic rea... | Deterioration in the stability of the reagents which has resulted in lower th... | Class III |
| Feb 13, 2018 | RaPET¿ RF Latex Reagent used as a component in the following kits: RaPET RF (... | All patient serum samples yield a weakly positive test result. | Class II |
| Feb 8, 2018 | Stanbio AC power adapter for the HemoPoint H2 meter, Model G3000 series. The... | The US prong (type A) adapter plate may crack, break, or detach and remain in... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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