Dimension Vista Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnostic product for the calibration of Creatine Kinase MB Isoenzyme (MMB) method on the Dimension Vista System.
FDA Recall Z-0024-2015 · Posted 2014-10-06
Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusTerminated
Product CodeJIT
Date Initiated2014-08-28
Date Terminated2015-03-30
Product Quantity6562
Reason for Recall
Siemens Healthcare Diagnostics has determined that Dimension Vista® Mass CKMB Isoenzyme Calibrator (MMB CAL) shows drift during routine stability monitoring that exceeds our acceptance criteria for drift over the shelf life of this product. Siemens has observed drift from 3% to 12% at MMB concentrations across the assay range. Depending on quality control limits, this drift may not have been d
Firm Action
An Urgent Medical Device Recall notice, dated August 2014, was provided to all Dimension Vista MMB CAL customers who received the affected lots to notify them of the issue, the potential risk to health, and actions to be taken by customers.
Customers were instructed to discard lots 3JD045, 4BD064, 4CD012, and 4DD065, and recalibrate with lot 4FD073.
Root Cause
Process design
Distribution Pattern
Worldwided distribution: US (nationwide) and countries of: Australia, Austria, Belgium, Canada, Denmark, Germany, Finland, France, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, Slovenia, South Korea, Spain, and Switzerland.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.