Z-2867-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 9, 2017
- Initiation Date
- May 22, 2017
- Termination Date
- September 4, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2356 kits Worldwide; US 206 kits
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.
Distribution Pattern
Nationwide Distribution
Code Information
Catalog Number 8L24-31: Lot Numbers: 60335Y600, 60382Y600 (Exp. Date 2018-02-28); Catalog Number 8L24-41: Lot Number: 60334Y600, (Exp. Date 2018-02-28)