FDA Updates the E. coli O145 Outbreak Notice for Frozen Berries: New Expanded Recall and a Chilean Producer That Did Not Provide All Records

The United States Food and Drug Administration (FDA) updated on October 5 the notice of its investigation into an outbreak of Shiga toxin-producing Escherichia coli O145:H28, linked to frozen organic blueberries and berry mixes. The outbreak was declared over on September 21, with 17 people infected in two states, Florida and Georgia, with symptom onsets between May 11 and early August, six hospitalizations and no deaths. The FDA clarifies that no new illnesses have been reported since the outbreak ended, but that potentially contaminated products keep appearing.

The central news is that on October 2 the Chilean producer and exporter of the fruit expanded its voluntary recall again to include other frozen organic blueberry and berry mix products sold in the United States under the own brands of large retail chains. According to the FDA, the expansion occurred after its investigators obtained new information during an on-site inspection abroad. The agency states that, during the investigation, the company did not provide all the records that had been requested voluntarily, and that it had already raised concerns about other products from the same firm that had not reached the US market. The FDA also added the firm to Import Alert 99-35, so its frozen blueberries can be detained at the border without physical examination until it is shown that the conditions that led to the measure have been resolved.

The notice recalls that the origin of the investigation was a notification from the Florida Department of Health on July 1 about a cluster of E. coli O145 cases. Interviews led to frozen organic blueberries from a retail chain, which stopped selling them, and to a first recall of a single lot. Later, the FDA reported that a product sample collected by the retailer tested positive for the outbreak strain, while its own samples of finished product in the United States were negative. Consumers are asked to check their freezer, discard the recalled products or return them to the place of purchase, and consult a doctor if they have severe diarrhea, cramps, fever or vomiting, symptoms that can appear up to nine days after eating the food. Some infections can lead to hemolytic uremic syndrome.

For producers and processors of frozen fruit, the case shows that a closed outbreak can reopen in the form of recalls if supplier verification fails, and that traceability and records are part of compliance. For the bacterial component, TAAG's Ampliora 3.9 kit, a real-time PCR, detects STEC and E. coli O157:H7 in lettuce, spinach, cabbage, mixed leafy greens and ground beef. Blueberries are not among its validated matrices, so its use here would require its own validation.