Recall Z-1133-2019

Reason for recall

Increased risk of false positive Enterobacteriaceae and Escherichia coli results on affected blood culture identification panels when using certain blood culture bottles.

FDA-determined cause: Material/Component Contamination

Action taken

On 03/07/19, Urgent: Medical Device Recall (Correction) notices were mailed to customers. Customers were informed that the false positive results are primarily Enterobacteriaceae results with a lower rate of concurrent E. coli results. If the affected BCID panel is used with BACT/ALERT blood culture bottles from the lots listed, then positive results for Escherichia coli and Enterobacteriaceae (if occurring without a specific genus/species reported other than E. coli; i.e. negative for all of the following: Enterobacter cloacae complex, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus, and Serratia marcescens) should be confirmed by another method prior to reporting the test results. Confirmation is not required if the Enterobacteriaceae detected result is accompanied by a detected result for Enterobacter cloacae complex, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus, or Serratia marcescens. Customers were asked to complete and return Acknowledgement of Receipt forms.