Dimension(R) EXL LOCI Cardiac Troponin I Calibrator (RC621) The LOCI Cardiac TNI Calibrator is an in vitro diagnostic pr

FDA device recall Z-0038-2012 · posted 2011-10-12 · Terminated

Recall details

Recalling firm

Siemens Healthcare Diagnostics, Inc.

Reason for recall

Internal testing has confirmed that recovery of levels 2 and 3 of LOCl Cardiac Troponin I Calibrator is lower than expected bottle value. Following calibration with LOCl Cardiac Troponin I Calibrator, lot 1AD045 an upward shift in patient and QC results may be observed.

Action taken

Siemens sent an Urgent Field Safety Notice dated August 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue use and discard any remaining inventory. Replacement orders would be processed and sent free of charge. Customers were also instructed to complete the attached FIELD CORRECTION EFFECTIVENESS CHECK form and fax it to (302) 631- 8457. Customers were instructed to forward the Safety Notice to anyone to whom they may have distributed the affected product. For any technical questions customers were to contact the Siemens Solutions Center at 800-441-9250.

Root cause

Other

Status

Terminated

Product code

JJE

Quantity affected

998

Distribution

Worldwide Distribution - USA (nationwide) including AL, AK, AZ, AR, CA, CO, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NM, NY, NC, OH, OK, OR, PA, SC, SD, TN,

Date initiated

2011-08-31

Date posted

2011-10-12

Date terminated

2013-05-20

Location

Newark, DE

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