Reported Sep 4, 2019 · Terminated
Phadia" 1000 Model # 12-3800-01 Product Usage: The instrument is fully integrated and automated instrument including…
Phadia Ab
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: Phadia Ab · Rapsgatan Plant · Uppsala, N/A · N/A
Is this the product you have?
- Phadia" 1000 Model # 12-3800-01
- Product UsageThe instrument is fully integrated and automated instrument including software for immunodiagnostic testing. The instrument is designed to handle all steps from sample and reagent handling to processing of results
- Lot codes and dates
- All Serial Numbers
- Unique Device Identifier (UDI)07333066001005
- Amount recalled
- 387 Instruments
Where it was sold
Why it was recalled
code 7-102 Liquid Sensor Error
This product could cause temporary or reversible health problems — stop using it.
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