FDA Medical Device Recalls (openFDA)
Remel, Inc: Yeastone Broth, 11ML, 10/BOX YY3462
- Recall number
- Z-1806-2026
- Recalling firm
- Remel, Inc
- Product
- Yeastone Broth, 11ML, 10/BOX YY3462
- Status
- Open, Classified
- Initiated
- 2026-03-24
- Posted
- 2026-04-10
- Terminated
- not on file
- Reason
- Products may report incorrect AST results during quality control. Health consequences may include delayed response or the need to change to another antifungal agent if laboratory ignores Quality Control test result.
- Root cause
- Under Investigation by firm
- Action
- Firm began notifying consignees on March 24, 2026 via letters titled "Urgent: Medical Device Recall." Customers were informed that the affected products may report incorrect AST results during quality control. Customers were asked to notify any personnel who need to be aware of the issue. Laboratory professionals are advised to review previously reported susceptibility results generated using affected lots and assess whether retesting is appropriate. Remaining inventory of affected lots must be destroyed; these lots should not be used for any clinical laboratory testing. The firm is investigating the root cause and will implement corrective and preventive actions to prevent future recurrence.
- Quantity
- 2819
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Vietnam, France, Argentina, Qatar, New Zealand, Uruguay, Turkey, Netherlands, Singapore.
- Lot, serial or model codes
- UDI-DI 848838018817 lots 321046, 329835, 330316, 327069, 330317, 336325, 338314, 341161, 303851, 311723
- 510(k) numbers
- ["K090968"]
- PMA numbers
- not on file
- Product code
- NGZ
- Firm FEI
- 1924669
- Firm city
- Lenexa
- Firm state
- KS
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28