Z-0334-2023Class I

Thermo SCIENTIFIC, Sensititre STP6F, Gram Negative IVD AST

Name: Z-0334-2023 Thermo SCIENTIFIC, Sensititre STP6F, Gram Negative IVD AST
Creator: Remel Inc
Published: 2022-10-20
License: https://open.fda.gov/license/

Remel Inc / initiated 2022-10-20 / Terminated / root cause: manufacturing process

FDA source

Remel Inc began a recall of Thermo SCIENTIFIC, Sensititre STP6F, Gram Negative IVD AST on 2022-10-20. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0334-2023
Classification: Class I
Status: Terminated
Initiated: 2022-10-20
Posted: 2022-12-08
Terminated: 2024-09-30
Recalling firm: Remel Inc
Product: Thermo SCIENTIFIC, Sensititre STP6F, Gram Negative IVD AST
Product code: JWY Manual Antimicrobial Susceptibility Test Systems
Reason for recall: 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 tag: manufacturing process
FDA 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 [email protected]. 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 [email protected].
Quantity in commerce: 2656 units
Distribution: US Nationwide Distribution
Product codes and lots: Lot Numbers: B2314, B2174, B2036, B1346, B1183, B1115, B1027

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0334-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0327-2023	Class I	Terminated	Voluntary: Firm initiated	2022-12-14	2022-12-07
Z-0328-2023	Class I	Terminated	Voluntary: Firm initiated	2022-12-14	2022-12-07
Z-0329-2023	Class I	Terminated	Voluntary: Firm initiated	2022-12-14	2022-12-07
Z-0330-2023	Class I	Terminated	Voluntary: Firm initiated	2022-12-14	2022-12-07
Z-0331-2023	Class I	Terminated	Voluntary: Firm initiated	2022-12-14	2022-12-07
Z-0332-2023	Class I	Terminated	Voluntary: Firm initiated	2022-12-14	2022-12-07
Z-0333-2023	Class I	Terminated	Voluntary: Firm initiated	2022-12-14	2022-12-07
Z-0334-2023	Class I	Terminated	Voluntary: Firm initiated	2022-12-14	2022-12-07
Z-0335-2023	Class I	Terminated	Voluntary: Firm initiated	2022-12-14	2022-12-07

Product code JWY

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)