—#144211

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.

FDA product code: NRP — Sirolimus Test System
Device class: Class 2
Medical specialty: Clinical Toxicology
510(k) numbers: K081857
Affected lot / code info: Lot # EB6064

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 500 Gbc Dr PO BOX 6101, Ms 514, Newark, Delaware 19702-2466

Distribution

Distribution pattern: Worldwide distribution and US including Puerto Rico and to the states of : TX, FL, CA, LA, DC, GA, IL, AR, WI, MI and MD.

Timeline

Recall initiated: 2016-02-09
Terminated: 2018-06-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #144211. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.