Recall record at a glance
| Official record | Z-2867-2017 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Sentinel CH SPA |
| Report date | Aug 9, 2017 |
| Recall initiation date | May 22, 2017 |
| Quantity | 2356 kits Worldwide; US 206 kits |
| Location | Milan, N/A, Italy |
Official 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
Why the product was recalled
Reagent 1 component may result in Quality Control values shifting out of acceptable range, which is not resolved by recalibration.
Distribution information
Nationwide Distribution
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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