FDA Device recall Z-2867-2017
MULTIGENT Creatinine (Enzymatic), Catalog Numbers 8L24-31 and 8L24-41
- FDA Device
- Class II
- terminated
- Published 2017-08-09
On 2017-08-09 the FDA classified a Class II recall of MULTIGENT Creatinine (Enzymatic), Catalog Numbers 8L24-31 and 8L24-41 by Sentinel Ch Spa, citing reagent 1 component may result in Quality Control values shifting out of acceptable range, which is not resolved by recalibration.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2867-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-05-22 |
| Published | 2017-08-09 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Sentinel Ch Spa |
| Distribution | US |
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
Reagent 1 component may result in Quality Control values shifting out of acceptable range, which is not resolved by recalibration.
Identifiers
| code_info | 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) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2867-2017%22
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