Reported Jan 8, 2014 · Terminated
AdvanDx Gram-Negative QuickFISH BC. In-Vitro Diagnostic for the identification of Enterobacteriacae Catalog Number:…
AdvanDx, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.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: AdvanDx, Inc. · 10a Roessler Rd · Woburn, MA · 01801-6208
Is this the product you have?
- AdvanDx Gram-Negative QuickFISH BC. In-Vitro Diagnostic for the identification
- of Enterobacteriacae Catalog NumberQFGNRBC1-25 Gram-Negative QuickFISH BC provides rapid identification of Escherichia coli, and/or Pseudomonas aeruginosa, and/or Klebsiella pneumoniae directly from GNR-positive blood cultures
- Lot codes and dates
- Lot codes US
04813C741308113 exp. 2013-12
- Lot codes OUS03113A 04213A 04813B
- Lot codes US
- Amount recalled
- 49 kits US; 17 kits OUS
Where it was sold
Why it was recalled
Kits incompatible with certain fluorescence microscope light sources
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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