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Terminated

Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format

FDA Recall Z-0722-2022 · Posted None

Recalling FirmRemel Inc
Recall StatusTerminated
Product CodeJWY
Date Initiated2022-01-10
Date Terminated2026-07-24
Product Quantity1210 devices

Reason for Recall

There are lower than expected MICs for some gram negative species.

Firm Action

A customer letter was issued to impacted consignees on or around 01/10/2022. Customers are asked to check for affected product and the recalling firm requests that customers do not report results of cefiderocol when affected product is used with Thermo Scientific Mueller-Hinton Broth with TES, catalong T3462, lots 267261 to 402775. Consignees are asked to disseminate the recall information within their organization and to any other organization to which affected products have been transferred. An acknowledgement form should be submitted by email to [email protected].

Root Cause

Under Investigation by firm

Distribution Pattern

Distribution throughout the United States.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K193538Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 µg/mlThermo Fisher Scientific · 2020-03-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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