Z-2867-2017Class II

MULTIGENT Creatinine (Enzymatic), Catalog Numbers 8L24-31 and 8L24-41; IVD. Intended for the quantitative...

Name: Z-2867-2017 MULTIGENT Creatinine (Enzymatic), Catalog Numbers 8L24-31 and 8L24-41; IVD. Intended for the quantitative...
Creator: Sentinel CH SPA
Published: 2017-05-22
License: https://open.fda.gov/license/

Sentinel CH SpA / initiated 2017-05-22 / Terminated / root cause: manufacturing process

FDA source

Sentinel CH SPA began a recall of MULTIGENT Creatinine (Enzymatic), Catalog Numbers 8L24-31 and 8L24-41; IVD. Intended for the quantitative determination of creatinine in human serum, plasma... on 2017-05-22. FDA classified it as Class II and gives the reason as "Reagent 1 component may result in Quality Control values shifting out of acceptable range, which is not resolved by recalibration". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2867-2017
Classification: Class II
Status: Terminated
Initiated: 2017-05-22
Posted: 2017-06-27
Terminated: 2018-09-04
Recalling firm: Sentinel CH SpA
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
Product code: JFY Enzymatic Method, Creatinine
Reason for recall: Reagent 1 component may result in Quality Control values shifting out of acceptable range, which is not resolved by recalibration.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Sentinel Diagnostics notified the US Distributor on 5/22/17 to notify US customers by letter. Actions to be Taken 1. Discontinue the use of the impacted lots immediately and destroy any remaining inventory of impacted lots according to your laboratory procedures. 2. If you have an alternate reagent lot available in inventory, switch to this alternate lot, or use a new lot provided. 3. Please review the content of this communication with your Medical Director and retain this letter for any future reference. Questions regarding this information, U.S. Customers should contact Customer Service at 1-877-4 ABBOTT. Customers to complete Field Safety Notice Receipt.
Quantity in commerce: 2356 kits Worldwide; US 206 kits
Distribution: Nationwide Distribution
Product codes and lots: 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)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2867-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2867-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-09	2017-08-03

Product code JFY

K073634Class IIMultigent Creatinine (Enzymatic) AssaySENTINEL CH. SpA / cleared 2008-06-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)