Z-0946-2015Class II

Dimension Vista Myoglobin Calibrator (MYO CAL), Lot 4FD085

Name: Z-0946-2015 Dimension Vista Myoglobin Calibrator (MYO CAL), Lot 4FD085
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2014-11-24
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2014-11-24 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Dimension Vista Myoglobin Calibrator (MYO CAL), Lot 4FD085 Product usage: in vitro diagnostic product for the calibration of Myoglobin (MYO) method on the... on 2014-11-24. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0946-2015
Classification: Class II
Status: Terminated
Initiated: 2014-11-24
Posted: 2015-01-08
Terminated: 2016-12-13
Recalling firm: Siemens Healthcare Diagnostics Inc.
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.
Product code: JIT Calibrator, Secondary
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.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 1230
Distribution: Worldwide Distribution: US (nationwide) and country of: Canada.
Product codes and lots: Lot 4FD085, exp. 12-01-2014

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0946-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0946-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-14	2015-01-08

Product code JIT

K053576Class IIDimension Vista Myo Reagent Cartridge and CalibratorDade Behring, Inc. / cleared 2006-02-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)