Elevated risk U.S. Food and Drug Administration

Church Brothers Green Onions recall: Recall Cancellation Due to False Positive

Recall published 1+ years ago

Recall Cancellation Due to False Positive

The hazard: Device malfunction

A malfunction was identified in this device. What matters most is whether your particular unit falls inside the affected model, lot or serial range.

What the notice says: Recall Cancellation Due to False Positive

Why it matters: The device may not perform as intended — a mechanical failure, a software defect, an inaccurate reading, or an alarm that does not sound. For a device someone depends on, the consequence of the failure is usually worse than the failure itself.

Symptoms and when to call a doctor

If the device supports a vital function, do not disable or remove it on your own judgement. Contact the clinician who prescribed or fitted it, and use the back-up arrangement they gave you. Go to an emergency department if the symptoms the device is meant to manage are getting worse, or if an implanted device gives an unexpected alarm or shock.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Published
November 25, 2024
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
Church Brothers
Product type
Fresh produce

Products covered by this recall

Green Onions

What the company announced

“Church Brothers, LLC has canceled their recall. For more information, please refer to the link at the end of this page."

Salinas, CA -- November 25, 2024 – The Canadian Food Inspection Agency (CFIA) has determined that a laboratory error incorrectly caused the October 18, 2024 recall announcement concerning Church Brothers Farms’ Green Onions. The products from Church Brothers did not contain Salmonella and the recall has been rescinded.

On October 18, 2024 Church Brothers Farms voluntarily recalled 1271 cases of Green Onions due to the potential to be contaminated with Salmonella . This action was based on information received from the CFIA that a single product sample had tested positive for its presence. While distribution of this product was limited to a small number of retail and foodservice customers in Canada and USA, Church Brothers acted quickly and in conjunction with both the CFIA and US FDA to ensure rapid compliance with the recall.

Following the positive Salmonella result, the CFIA completed the whole genome sequencing (WGS) analysis of the Salmonella isolate, the results of which indicated that the sample could have been cross-contaminated with the laboratory’s positive control strain.

After further internal review, the CFIA conclusively determined that cross-contamination had indeed occurred. The CFIA also confirmed that the cross-contamination was an isolated event, and no other samples were affected.

Given this cross-contamination, the CFIA has rescinded the food recall and removed the notification that was published on the Government of Canada’s Recalls and Safety Alerts website.

“The safety of our products is Church Brothers’ highest priority, and we pride ourselves with having the utmost integrity when it comes to Food Safety Standards,” said Megan Chedwick, Vice President of Food Safety, Quality & Regulatory Compliance at Church Brothers Farms. “While we were pleased to hear that our product did not contain the Salmonella isolate, we will always act with an abundance of caution when it comes to the health and well-being of our consumers.”

This is a correction to the press release issued on October 18, 2024 with the headline of “Church Brothers Farms Recall Green Onions Due to Possible Health Risk.”

Company Contact Information

Church Brothers Farms

Consumer Hotline 877-590-0428

[email protected]

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

What to do about Malfunction

Church Brothers — A malfunction was identified in this device. What matters most is whether your particular unit falls inside the affected model, lot or serial range.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers listed on this page.
  2. Check whether the remedy is a software update, and if so confirm afterwards in the device menu that the version actually changed.
  3. If you are a clinic or facility, quarantine affected stock and record the correction in your recall log.
  4. Report device problems to the FDA through MedWatch — that database is where this recall came from.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

Company contact: Church Brothers — Consumers: Church Brothers Farms Consumer Hotline, 877-590-0428, [email protected]

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Church Brothers fresh produce recalled?

Recall Cancellation Due to False Positive Recall Cancellation Due to False Positive

How do I know if I have the recalled product?

The notice does not publish package codes for this recall. Compare the product name, size and the purchase window against the official FDA — Company recall announcements record, and contact the company if you are unsure.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers listed on this page.

Can I get my money back?

If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.

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