MULTIGENT Creatinine — Class II medical device recall Z-2867-2017
Terminated recall by Sentinel CH SPA, reported 2017-08-09, distributed nationwide. Reagent 1 component may result in Quality Control values shifting out of acceptable range, which is not resolv
| Recall number | Z-2867-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sentinel CH SPA, Milan, N/A, Italy |
| Recall initiated | 2017-05-22 |
| Classified | 2017-08-03 |
| Reported by FDA | 2017-08-09 |
| Terminated | 2018-09-04 |
| Distributed | Nationwide (US) |
| Lot numbers | 60334Y600, 60335Y600, 60382Y600 |
| Model numbers | 8L24-31, 8L24-41 |
| Expiration dates | 2018-02-28 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2867-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.