—#132004

Product

Dimension Vista Myoglobin Calibrator (MYO CAL), Lot 4FD085 Product usage: in vitro diagnostic product for the calibration of Myoglobin (MYO) method on the Dimension Vista System.

FDA product code: JIT — Calibrator, Secondary
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K053576
Affected lot / code info: Lot 4FD085, exp. 12-01-2014

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

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: US (nationwide) and country of: Canada.

Timeline

Recall initiated: 2014-11-24
Posted by FDA: 2015-01-08
Terminated: 2016-12-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #132004. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.