Data Foundry

Medical device recalls 2013

Diagnostic Hybrids — Class III medical device recall Z-0792-2013

Terminated recall by Diagnostic Hybrids Inc, reported 2013-02-13, distributed nationwide. RhMK product fungal contamination.

Recall numberZ-0792-2013
Product typeMedical device
ClassificationClass III
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmDiagnostic Hybrids Inc, Athens, OH, United States
Recall initiated2012-12-31
Classified2013-02-07
Reported by FDA2013-02-13
Terminated2013-12-05
DistributedNationwide (US)
Quantity13,005 units
Reason classesmicrobial contamination
Pathogensmold
Lot numbers491206T, 491216, A-491206T, A-491216, A-491216B
Model numbers49-0102A, 49-0600, 49-0600A, 49-T075A

Product

Diagnostic Hybrids, Inc., RhMK, Model #:49-0600, 49-0600A, 49-0102A, and 49-T075A. Culture media, used in the cultivation and amplification of viruses, such as respiratory viruses, enteroviruses, measles, and poliovirus from patient specimens.

Reason for recall

RhMK product fungal contamination.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0792-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.