Remel, Inc. Issues Recall for Campy CVA Medium Over Bacterial Recovery Concerns
Remel, Inc. is recalling specific lots of Campy CVA Medium after reports showed the product failed to properly recover Campylobacter Jejuni, potentially affecting lab results.
What Happened
Remel, Inc. has initiated a voluntary recall of its Campy CVA Medium (100/PK) following customer complaints. The reports indicate that the specific lot of medium showed low to no recovery of Campylobacter Jejuni ATCC 33291. This performance defect was identified through firm-initiated testing and feedback.
Which Products Are Affected
The recall involves 97 units of the following product:
- Product Name: Campy CVA Medium 100/PK, R01272
- Recall Number: Z-1474-2026
- UDI-DI: 848838001055
- Lot Numbers: R01272, lot 339135
- Expiration Date: January 12, 2026
The affected products were distributed to healthcare and laboratory facilities in Arizona, Colorado, Illinois, New Jersey, Ohio, Tennessee, and Washington.
What You Should Do
Laboratories and distributors should immediately check their inventory for the affected lot numbers. Remel, Inc. notified customers via letter on February 5, 2026. If you have the recalled product, you should follow the instructions provided in the notification letter regarding the quarantine and return of the items.
Why This Matters
The inability of the medium to recover the target pathogen, Campylobacter Jejuni, can lead to false-negative laboratory results. This poses a risk to patient health by potentially delaying or preventing the correct diagnosis of bacterial infections.
Source
Information provided by the FDA.
Source: FDA Official Notice