Dimension Vista Myoglobin Calibrator (MYO CAL), Lot 4FD085 Product usage: in vitro diagnostic product for the calibratio

FDA device recall Z-0946-2015 · posted 2015-01-08 · Terminated

Recall details

Recalling firm

Siemens Healthcare Diagnostics, Inc.

Reason for recall

Dimension Vista Myoglobin Calibrator (MYO CAL) may produce a positive shift in MYO QC and Patient test results that exceeds acceptance criteria for this product. A positive shift observed up to 12% at MYO concentrations within and above the reference range of the assay. Depending on quality control limits, this drift may not be detected.

Action taken

The firm, Siemens, sent an "Urgent Medical Device Recall"letter dated November 2014, to all customers who received the affected lot. The letter described the product, problem and actions to be taken. The customers were instructed to: Review this letter with your Medical Director; discard your remaining inventory; recalibrate with an alternate in-date lot of MYO CAL, and complete and return the attached Field Correction Effectiveness Check Form and fax the form to (312) 275-7795. Siemens will replace any unused inventory of the affected lot at no charge. If you have any questions, please contact your Siemens Customer Care Center - Technical Solutions at 800-441-9250 or your local Siemens technical support representative.

Root cause

Under Investigation by firm

Status

Terminated

Product code

JIT

Quantity affected

1230

Distribution

Worldwide Distribution: US (nationwide) and country of: Canada.

Date initiated

2014-11-24

Date posted

2015-01-08

Date terminated

2016-12-13

Location

Newark, DE

Related 510(k) clearances