Z-1633-2016Class II

Dimension clinical chemistry system, Sirolimus (SIRO) Flex reagent cartridge (DF306 SMN 10464331) Lot EB6064...

Name: Z-1633-2016 Dimension clinical chemistry system, Sirolimus (SIRO) Flex reagent cartridge (DF306 SMN 10464331) Lot EB6064...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2016-02-09
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2016-02-09 / Terminated

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Dimension clinical chemistry system, Sirolimus (SIRO) Flex reagent cartridge (DF306 SMN 10464331) Lot EB6064, Open Well Instability The SIRO method is an in... on 2016-02-09. FDA classified it as Class II and gives the reason as "Siemens Healthcare Diagnostics has received customer complaints regarding QC shifts and imprecision after one day when using Dimension SIRO lot EB6064. They have confirmed SIRO lot # EB6064 does not meet the open well...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1633-2016
Classification: Class II
Status: Terminated
Initiated: 2016-02-09
Posted: 2016-05-10
Terminated: 2018-06-12
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Dimension clinical chemistry system, Sirolimus (SIRO) Flex reagent cartridge (DF306 SMN 10464331) Lot EB6064, Open Well Instability The SIRO method is an in vitro diagnostic test for the quantitative measurement of sirolimus in whole blood on the Dimension clinical chemistry system.
Product code: NRP Sirolimus Test System
Reason for recall: Siemens Healthcare Diagnostics has received customer complaints regarding QC shifts and imprecision after one day when using Dimension SIRO lot EB6064. They have confirmed SIRO lot # EB6064 does not meet the open well stability claim of 2 days.
FDA root cause: Under Investigation by firm
Action: Siemens sent an "URGENT MEDICAL DEVICE RECALL" letter dated February 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions to be Taken by the Customer: Discontinue use of and discard the kit lot listed in Table 1. Please review this letter with your Medical Director. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. If you have received any complaints of illness or adverse events associated with the product listed in Table 1, immediately contact your local Siemens Customer Care Center or your local Siemens technical support representative. Please retain this letter with your laboratory records, and forward this letter to those who may have received this product. We apologize for the inconvenience this situation may cause. If you have any questions, please contact your Siemens Customer Care Center or your local Siemens technical support representative. For further questions, please call (302) 631-0528.
Quantity in commerce: 394
Distribution: Worldwide distribution and US including Puerto Rico and to the states of : TX, FL, CA, LA, DC, GA, IL, AR, WI, MI and MD.
Product codes and lots: Lot # EB6064

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1633-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1633-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-18	2016-05-10

Product code NRP

K081857Class IIDimension Siro Flex Reagent Cartridge and Dimension Sirolimus Calbirator, Models Dr 306, Dc 306Siemens Healthcare Diagnostics, Inc. / cleared 2008-10-30

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)