Dimension Vista Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnostic product for the calibration of Creatine
FDA device recall Z-0024-2015 · posted 2014-10-06 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- 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
- Action taken
- 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
- Status
- Terminated
- Product code
- JIT
- Quantity affected
- 6562
- Distribution
- Worldwided distribution: US (nationwide) and countries of: Australia, Austria, Belgium, Canada, Denmark, Germany, Finland, France, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, Slove
- Date initiated
- 2014-08-28
- Date posted
- 2014-10-06
- Date terminated
- 2015-03-30
- Location
- Newark, DE
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DIMENSION VISTA INTEGRATED SYSTEM (K051087) | Dade Behring, Inc. | 2005-07-11 |