Recall Z-0792-2013— Diagnostic Hybrids Inc
Class III · Terminated
Class III FDA medical device recall by Diagnostic Hybrids Inc, initiated 2012-12-31, terminated 2013-12-05. FDA's recall record names no specific 510(k) clearance for this event. 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: RhMK product fungal contamination..
- Recalling firm
- Diagnostic Hybrids Inc
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2012-12-31
- Terminated
- 2013-12-05
- Firm location
- Athens, OH, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.