ETEST® Erythromycin (EM)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.

5 other recalls cover devices cleared under the same FDA submission (K913459); 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, 2022Class IIOpen, Classified

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

   Z-0823-2023 · Root cause: Storage · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K913459. One submission often covers many models, so check the product and lot details in each record.

• Z-0819-2023 · Nov 9, 2022 · Open, Classified
  ETEST CLINICAL AMOXI/CLAV 2/1 XL 256 US S30, CATALOG 412252
• Z-0265-2018 · Apr 13, 2017 · Terminated
  ETEST OXACILLIN OX 256 WW F100 In vitro diagnostic, a quantitative technique for determining the antimicrobial susceptibility of bacteria species.
• Z-0264-2018 · Apr 13, 2017 · Terminated
  ETEST OXACILLIN OX 256 US F100 In vitro diagnostic, a quantitative technique for determining the antimicrobial susceptibility of bacteria species.
• Z-1530-2017 · Dec 15, 2016 · Terminated
  ETEST Gentamicin GM256 FOAM packaging, Product Name: ETEST Gentamicin GM 0.016-256(low). ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-
• Z-1522-2017 · Dec 15, 2016 · Terminated
  ETEST Cephalotin CE 256 Foam packaging, Product Name: ETEST Cephalothin CE 0.016-256. ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-neg