Recall Z-2867-2017— Sentinel CH SPA

Name: FDA recall Z-2867-2017
Creator: U.S. Food and Drug Administration
Published: 2017-05-22

Class II · Terminated

Class II FDA medical device recall by Sentinel CH SPA, initiated 2017-05-22, terminated 2018-09-04. It names one FDA 510(k) clearance: K073634. Product: MULTIGENT Creatinine (Enzymatic), Catalog Numbers 8L24-31 and 8L24-41; IVD. Intended for the quantitative determination of creatinine in human serum, plasma, and urine using the ARCHITECT c Systems The product is a medical device (chemistry reagent) and is intended for the quantitative determination of creatinine in human serum, plasma, and urine using the ARCHITECT c Systems. The kit is provided as a ready to use liquid material consisting in two components: Reagent 1 and Reagent 2. According to the catalogue number, the kit is composed of three vials of 48 ml for Reagent 1 and three vials of 18 ml for Reagent 2 in the configuration 8L24-31. The configuration 8L24-41 consists in ten vials of 90 ml for Reagent 1 and ten vials of 34 ml for Reagent 2. Reason: Reagent 1 component may result in Quality Control values shifting out of acceptable range, which is not resolved by recalibration..

Recalling firm: Sentinel CH SPA
Classification: Class II
Status: Terminated
Initiated: 2017-05-22
Terminated: 2018-09-04
Firm location: Milan, N/A, Italy

510(k) clearances named in this recall

1 on FDA's record

K073634 — MULTIGENT CREATININE (ENZYMATIC) ASSAYSENTINEL CH. SpA·cleared 2008-06-19

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

MULTIGENT Creatinine (Enzymatic), Catalog Numbers 8L24-31 and 8L24-41; IVD. Intended for the quantitative determination of creatinine in human serum, plasma, and urine using the ARCHITECT c Systems The product is a medical device (chemistry reagent) and is intended for the quantitative determination of creatinine in human serum, plasma, and urine using the ARCHITECT c Systems. The kit is provided as a ready to use liquid material consisting in two components: Reagent 1 and Reagent 2. According to the catalogue number, the kit is composed of three vials of 48 ml for Reagent 1 and three vials of 18 ml for Reagent 2 in the configuration 8L24-31. The configuration 8L24-41 consists in ten vials of 90 ml for Reagent 1 and ten vials of 34 ml for Reagent 2

Reason for recall

Reagent 1 component may result in Quality Control values shifting out of acceptable range, which is not resolved by recalibration.

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