—#196736

Product

Thermo SCIENTIFIC, Sensititre GN6F, Gram Negative IVD AST

FDA product code: JWY — Manual Antimicrobial Susceptibility Test Systems
Device class: Class 2
Medical specialty: Microbiology
510(k) numbers: K060621, K073424, K860753, K880641, K936305, K983244
Affected lot / code info: Lot Numbers: B2247, B2096, B1445, B1263, B1176, B0503A

Why it was recalled

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 (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Remel Inc
Address: 12076 Santa Fe Trail Dr, Lenexa, Kansas 66215-3519

Distribution

Distribution pattern: US Nationwide Distribution

Timeline

Recall initiated: 2022-10-20
Posted by FDA: 2022-12-08
Terminated: 2024-09-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #196736. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.