Roche Recalls Influenza Quality Control Kits Due to Incorrect Expiration Dates
Roche Molecular Systems is recalling 194 cobas Liat Influenza A/B Quality Control Kits because they are labeled with incorrect expiration dates.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA 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. The issue is a documentation/labeling error regarding expiration dates.
Plain-English summary
Roche Molecular Systems, Inc. is recalling 194 units of the cobas Liat Influenza A/B Quality Control Kit. The recall is being conducted because the kits are labeled with the incorrect expiration date. The affected lot numbers are 51222E, 60121H, 60201D, and 60229F.
The affected kits were distributed in the states of Texas, New York, Oregon, Hawaii, Maryland, Pennsylvania, North Carolina, Massachusetts, Iowa, Washington, Alaska, Maine, Minnesota, Virginia, Montana, and Louisiana. The kits are intended for use with the cobas Liat Influenza A/B Assay.
The U.S. Food and Drug Administration has classified this recall as Class III. This classification indicates that use of or exposure to the violative product is not likely to cause adverse health consequences. Users should stop using the affected kits and contact Roche Molecular Systems for instructions on return or replacement.
The recalled product
- Product
- cobas¿ Liat Influenza A/B Quality Control Kit; For use with cobas¿ Liat Influenza A/B Assay.
- Manufacturer
- Roche Molecular Systems, Inc.
- Hazard
- Affected units
- 194
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 (4)
- Lot Numbers: 51222E
- 60121H
- 60201D
- and 60229F
Distribution
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