ADVIA Centaur Systems TnI-Ultra assay; Catalog Number 02789602 (100 tests), SMN 10317708 and 02790309 (500 tests), SMN 1

FDA device recall Z-1991-2014 · posted 2014-07-02 · Terminated

Recall details

Recalling firm

Siemens Healthcare Diagnostics, Inc

Reason for recall

The solid phase reagent in some of the ADVIA Centaur TnI -Ultra ReadyPacks, lot 084, is darker in appearance, creating a potential for incorrect control and patient results.

Action taken

An Urgent medical Device Correction (UMDC) was mailed, via FedEx, to all affected Siemens Healthcare Diagnostics customers in the United States on May 30, 2014 for customer receipt on June 2, 2014. All international customers were provided with a copy of the Urgent Field Safety Notice via hard copy, e-mail, and/or fax as determined by each country's local regulations and procedures. Each customer is asked to complete a fax-back form. This notice informed the customers of the potential for incorrect control and patient results due to solid phase which is darker in appearance. The notice instructs customers to place one TnI-Ultra ReadyPack on the system at a time and to calibrate and run controls on each ReadyPack to ensure accurate control and patient values. Patient TnI-Ultra results produced with this assay are acceptable if they follow acceptable calibration with valid quality control results. Upon receipt of kit lots ending in 086 and higher, calibration of each ReadyPack is not required. This notice should be reviewed with the facility's laboratory or medical director.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

MMI

Quantity affected

34,283 kits

Distribution

Worldwide Distribution-USA (nationwide) including PR and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NJ, NM, NV, NY, OH, OK, OR, P

Date initiated

2014-05-30

Date posted

2014-07-02

Date terminated

2016-02-26

Location

East Walpole, MA

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