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Terminated

MedSchenker Smart Transport Medium (STM) System: CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL - MULTIPURPOSE CULTURE MEDIUM - Product Usage: intended for the collection and transport of clinical specimens containing viruses, from the collection site to the testing laboratory. I

FDA Recall Z-1417-2021 · Posted None

Recalling FirmVectornate USA Inc
Recall StatusTerminated
Product CodeJSG
Date Initiated2021-02-16
Date Terminated2022-12-08
Product Quantity130,000 devices

Reason for Recall

Discoloration and turbidity were present in the specified lots of STMs because of Longer Monsoon season at the South Korean Manufacturing Facility.

Firm Action

The firm did not give out a public statement of a recall or recall strategy as it only affected one client and was specific to two identified lots. the firm did notify the customer of the issue via phone and email.

Root Cause

Process control

Distribution Pattern

US Nationwide distribution in the state of NJ.

Official Source

View FDA Recall →

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

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