Food, drugs, devices › Stanbio Laboratory, LP
Device recall: RaPET¿ RF Latex Reagent used as a component in the following kits: RaPET RF (1155-100, Control# 173201 expiry 2019-04-30
Stanbio Laboratory, LP (Boerne, TX) initiated this device recall on 13 Feb 2018; FDA lists 1 product record under event 79245, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 92% of the 1,074 device enforcement events initiated in 2018 carry the same class.
Status: Terminated, terminated 27 Sep 2018. Initiation: voluntary: firm initiated. Stanbio Laboratory, LP has 5 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Stanbio Laboratory, LP, Boerne, TX.
Reason for recall
"All patient serum samples yield a weakly positive test result."
Distribution
"Worldwide Distribution - United States nationwide , Canada, Korea, Mexico, Trinidad"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| 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 expiry 2019-09-30 and Control # 173262 expiry 2019-12-31) Product Usage: RaPET¿ RF is intended for the… | 686 units | Class II | Terminated | 21 Mar 2018 |
Context
Other enforcement events for Stanbio Laboratory, LP
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 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 |
| 16 Mar 2022 | Separation Technology Creamatocrit Plus, Catalog Number: 100-146 | Device | Class II | 1 |
| 12 Jul 2021 | Beta-Hydroxybutyrate LiquiColor. in vitro diagnostic reagent. | Device | Class III | 5 |
| 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 | Device | Class II | 1 |
All 5 events for Stanbio Laboratory, LP
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "All patient serum samples yield a weakly positive test result."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution - United States nationwide , Canada, Korea, Mexico, Trinidad"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 27 Sep 2018. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.