Device 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
Z-2867-2017
Product summary
- Firm
- Sentinel CH SPA
- Event
- Event 77405
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2356 kits Worldwide; US 206 kits
- Official record key
device-enforcement:Z-2867-2017
Official wording
Reason: Reagent 1 component may result in Quality Control values shifting out of acceptable range, which is not resolved by recalibration.
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)
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
Reagent 1 component may result in Quality Control values shifting out of acceptable range, which is not resolved by recalibration.