Recall Z-2200-2021— Stanbio Laboratory, LP

Name: FDA recall Z-2200-2021
Creator: U.S. Food and Drug Administration
Published: 2021-07-12

Class III · Terminated

Class III FDA medical device recall by Stanbio Laboratory, LP, initiated 2021-07-12, terminated 2022-03-29. It names one FDA 510(k) clearance: K910108. Product: Beta-Hydroxybutyrate Reagent A - Enzyme (unlabeled). in vitro diagnostic reagent.. Reason: Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values..

Recalling firm: Stanbio Laboratory, LP
Classification: Class III
Status: Terminated
Initiated: 2021-07-12
Terminated: 2022-03-29
Firm location: Boerne, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K910108 — GDS ENZYMATIC B-HYDROXYBUTYRATE REAGENT MODIFIEDGds Diagnostics·cleared 1991-03-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Beta-Hydroxybutyrate Reagent A - Enzyme (unlabeled). in vitro diagnostic reagent.

Reason for recall

Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.

Data sourced from openFDA. This site is unofficial and independent of the FDA.