Diagnostic Hybrids RhMK Culture Media Recalled for Fungal Contamination
Diagnostic Hybrids is recalling RhMK culture media due to fungal contamination. The affected products are used to cultivate viruses from patient specimens.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Diagnostic Hybrids, Inc. is recalling specific models of RhMK culture media, including models 49-0600, 49-0600A, 49-0102A, and 49-T075A. These products are used in the cultivation and amplification of viruses, such as respiratory viruses, enteroviruses, measles, and poliovirus, from patient specimens.
The recall is being conducted because the RhMK product was found to be contaminated with fungi. A total of 13,005 units were distributed nationwide, including to facilities in 35 states. The affected units are identified by specific model numbers and lot numbers, such as 491206T and 491216.
The FDA has classified this recall as Class III, which indicates that use of or exposure to the violative product is not likely to cause adverse health consequences. Users of these products should stop using the affected lots and contact Diagnostic Hybrids, Inc. for further instructions or a refund.
The recalled product
- 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.
- Manufacturer
- Diagnostic Hybrids Inc
- Hazard
- Affected units
- 13,005
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- Model #:49-0600
- Lot#
- 491206T
- 491216
- Model #: 49-0600A
- -A-491206T
- -A-491216
- -A-491216B
- Model #: 49-0102A
- -A-491216 and Model #: 49-T075A
- -A-491216.
Distribution
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