ETEST® Ceftriaxone (TX)Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

2 other recalls cover devices cleared under the same FDA submission (K980345); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Nov 9, 2022Open, Classified

   As the temperature and time out of range was exceeded, product performances cannot be guaranteed

   Z-0821-2023 · Root cause: Storage · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K980345. One submission often covers many models, so check the product and lot details in each record.

• Z-1532-2017 · Dec 15, 2016 · Terminated
  ETEST Ceftriaxone TXL32 FOAM packaging, Product Name: ETEST Ceftriaxone TX 0.002-32(low). ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram
• Z-1523-2017 · Dec 15, 2016 · Terminated
  ETEST Ceftriaxone TXL32 SPB, Product Name: ETEST Ceftriaxone TX 0.002-32(low). ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative a