FDA recall Z-2867-2017

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 for recall

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

Distribution

Nationwide Distribution

Key facts

Status

Terminated

Initiation date

2017-05-22

Report date

2017-08-09

Termination date

2018-09-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Milan, N/A, Italy

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2867-2017