Reported Aug 9, 2017 · Terminated
MULTIGENT Creatinine (Enzymatic), Catalog Numbers 8L24-31 and 8L24-41; IVD. Intended for the quantitative determination…
Sentinel CH SPA
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sentinel CH SPA · Via Robert Koch 2 · Milan, N/A · N/A
Is this the product you have?
- 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 componentsReagent 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
- Lot codes and dates
- Catalog Number 8L24-31Lot
- Numbers
60335Y60060382Y600 (Exp. Date 2018-02-28)
- Catalog Number 8L24-41Lot
- Number
60334Y600(Exp. Date 2018-02-28)
- Amount recalled
- 2356 kits Worldwide; US 206 kits
Where it was sold
- Nationwide
Why it was recalled
Reagent 1 component may result in Quality Control values shifting out of acceptable range, which is not resolved by recalibration.
This product could cause temporary or reversible health problems — stop using it.
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