FDA Medical Device Recalls (openFDA)
Remel Inc: Thermo SCIENTIFIC Sensititre Plate, GN4F, Gram Negative IVD AST
- Recall number
- Z-0327-2023
- Recalling firm
- Remel Inc
- Product
- Thermo SCIENTIFIC Sensititre Plate, GN4F, Gram Negative IVD AST
- Status
- Terminated
- Initiated
- 2022-10-20
- Posted
- 2022-12-08
- Terminated
- 2024-09-30
- Reason
- An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp., Morganella Morganii) when tested with doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam and aztreonam.
- Root cause
- Process control
- Action
- The firm issued an "Urgent Medical Device Correction" notice to its consignees on 10/25/2022 by US mail. The notice explained the issue, risk to health, and notified the consignees of an update to the IFU, specifically, "to add limitations for Carbapenems (Imipenem, Doripenem, Meropenem, Ertapenem), Cefepime, Piperacillin/Tazobactam and Aztreonam added for users to "NOT REPORT" any result for each member of the Protea tribe (including Proteus spp., Providencia spp., Morganella Morganii) to address false susceptible results." Please complete and return the Required Customer Reply form via email to MBD.vigilance@thermofisher.com. Please keep this notification on file. The notice needs to be passed on to all who need to be aware within your organization or to any organization where the potentially affected products have been transferred. This correction notification is being made and performed by the US agent, Remel Inc., on behalf of the Foreign Manufacturer of the affected product, Trek Diagnostic Systems Ltd., located in East Grinstead, UK. Trek Diagnostic Systems and Remel Inc., both part of Thermo Fisher Scientific, are investigating the root cause and will implement corrective actions to prevent future recurrence. If you have any questions, please contact our Technical Services Department at 800-255-6730 (US) or email microbiology.ts.us@thermofisher.com.
- Quantity
- 1917 units
- Distribution
- US Nationwide Distribution
- Lot, serial or model codes
- Lot Numbers: B2232B, B2197, B2012, B1355, B1181, B1173, B1125A
- 510(k) numbers
- ["K060621","K073424","K860753","K880641","K936305","K983244"]
- PMA numbers
- not on file
- Product code
- JWY
- 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