—#129748

Product

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 product code: JIT — Calibrator, Secondary
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K051087
Affected lot / code info: lot 3JD045, exp. 2014-10-01; lot 4BD064, exp. 2015-02-01; lot 4CD012, exp. 2015-03-01; and lot 4DD065, exp. 2015-05-01.

Why it was recalled

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

Root cause (FDA determination)

Process design

Action the firm took

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.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 500 Gbc Dr PO BOX 6101, Ms 514, Newark, Delaware 19702-2466

Distribution

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.

Timeline

Recall initiated: 2014-08-28
Posted by FDA: 2014-10-06
Terminated: 2015-03-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #129748. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.