Reported Sep 2, 2015 · Terminated
Dimension Vista B¿2-Microglobulin Flex Reagent Cartridge (B2MIC); Product Usage: The B2MIC method is an in vitro…
Siemens Healthcare Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Healthcare Diagnostics, Inc. · 500 Gbc Dr Ms 514 · Newark, DE · 19702-2466
Is this the product you have?
- Dimension Vista B¿2-Microglobulin Flex Reagent Cartridge (B2MIC)
- Product UsageThe B2MIC method is an in vitro diagnostic test for the quantitative measurement of B¿2-Microglobulin in human serum, heparinized plasma, EDTA plasma and urine on the Dimension Vista System. Measurements of B¿2-Microglobulin aid in the diagnosis of active rheumatoid arthritis and kidney disease
- Lot codes and dates
- Lot Number15037MA
- ExpDate2016-07-14 Lot # 15175MA
- ExpDate
2015-11-17Lot # 15204MA
- Expdate
2017-01-13Lot #15246MA
- expdate2017-02-26 Lot # 15267MA
- expdate2017-02-26
- Amount recalled
- Total 1655 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Siemens Healthcare Diagnostics, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.