Reported Apr 8, 2015 · Terminated
BD FACSCalibur; Catalog Numbers 342973, 342975, 34976 In vitro Diagnostics Use.
BD Biosciences, Systems & Reagents
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: BD Biosciences, Systems & Reagents · 2350 Qume Dr · San Jose, CA · 95131-1812
Is this the product you have?
BD FACSCaliburCatalog Numbers 34297334297534976 In vitro Diagnostics Use
- Lot codes and dates
71 of 71 codes
Serial Nos. E34297300656E34297300657E34297300659E34297300660E34297300661E34297300666E34297300667E34297300668E34297300669E34297300670E34297300671E34297300673E34297300675E34297300676E34297300677E34297300678 E34297502563E34297502564E34297502565E34297502566E34297502567E34297502568E34297502569E34297502570E34297502571E34297502572E34297502573E34297502574E34297502575E34297502576E34297502577E34297502578E34297502579E34297502580E34297502581E34297502583E34297502584E34297502585E34297502586E34297502587E34297502588E34297502589E34297502590E34297502591E34297502592E34297502593E34297502594E34297502595E34297502596E34297502597E34297502599E34297502600E34297502601E34297502602E34297502603E34297502604E34297502605E34297502606E34297502607E34297502608E34297502612
- Amount recalled
- 72 devices
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
The circuit breakers on some BD FACSCalibur instruments may have the incorrect rated amperage (20 amps instead of 2 amps) causing the circuit breaker to fail to open in an over-current situation.
This product could cause temporary or reversible health problems — stop using it.
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