Dimension Vista Enzyme 1 Calibrator (ENZ 1 CAL) lots 3FD034 and 3HD012. An in vitro diagnostic multi-analyte calibrator
FDA device recall Z-1076-2014 · posted 2014-02-24 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Reason for recall
- Complaints were received regarding Quality Control (QC) shifts with Pseudocholinesterase (PCHE) and imprecision during PCHE calibration with the Dimension Vista Enzyme 1 Calibrator (ENZ 1 CAL).
- Action taken
- A recall notification letter, dated January 2014, was sent to Users.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- JIX
- Quantity affected
- 3496
- Distribution
- Nationwide Distribution.
- Date initiated
- 2014-01-06
- Date posted
- 2014-02-24
- Date terminated
- 2015-05-06
- Location
- Newark, DE
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DIMENSION VISTA ENZYME 1 CALIBRATOR (ENZ 1 CAL - KC310) (K061923) | Dade Behring, Inc. | 2006-08-25 |