Dimension Vista B2-Microglobulin Flex Reagent Cartridge (B2MIC); Product Usage: The B2MIC method is an in vitro diagnost
FDA device recall Z-2450-2015 · posted 2015-08-22 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Reason for recall
- customers are receiving a high number of Abnormal Assay Errors or are not able to calibrate B2MIC when using Flex reagent cartridge B2MIC various lots. In failure mode, there is the potential for falsely depressed beta2-Microglobulin results on the Dimension Vista system due to assay reagent contamination.
- Action taken
- Siemens sent an Urgent Medical Device Correction letter dated July 2015 to all affected customers. The letter identified the affected product, problem, risk to health, and actions to be taken by customers. For questions contact your Customer Care Center - Technical Solutions at 1-800-441-9250 or your local Siemens technical support representative.
- Root cause
- Environmental control
- Status
- Terminated
- Product code
- JZG
- Quantity affected
- Total 1655 units
- Distribution
- US Nationwide Distribution in the states of TN, AZ, CT, Fl, CA, NY and WI
- Date initiated
- 2015-07-23
- Date posted
- 2015-08-22
- Date terminated
- 2017-03-24
- Location
- Newark, DE
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DIMENSION VISTA BETA 2 MICROGLOBULIN, DIMENSION VISTA PROTEIN 1 CALIBRATOR, DIMENSION VISTA PROTEIN 1 CONTROL M (K083463) | Siemens Healthcare Diagnostics | 2009-03-13 |