Roche cobas p 501 Post-Analytical Units Recalled for Loose Flap
Roche Diagnostics is recalling four cobas p 501 post-analytical units because the tray input flap may become loose and detach from the instrument.
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 as a Class III recall, which by definition is unlikely to cause adverse health consequences, aligning with the 'Low' severity criteria for minor or theoretical risks.
Plain-English summary
Roche Diagnostics Corporation is recalling four units of the cobas p 501 post-analytical units, Part Number 05158494001. These devices are used for diagnostic sample storage and retrieval. The affected units have serial numbers ranging from 1001 through 1044.
The recall is due to a potential defect where the tray input flap on the post-analytical units may become loose and detach from the instrument. The FDA has classified this recall as Class III, indicating that use of the product is not likely to cause adverse health consequences.
The affected units were distributed nationwide in the states of Alabama, California, Florida, Iowa, Illinois, Kentucky, Maryland, Oregon, and Pennsylvania. Users of these devices should contact Roche Diagnostics Corporation for further instructions on how to proceed.
The recalled product
- Product
- cobas p 501 post-analytical units, Part Number 05158494001. For diagnostic sample storage and retrieval.
- Manufacturer
- Roche Diagnostics Corporation
- Hazard
- Affected units
- 4
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 (1)
- Serial Numbers - 1001 through 1044
Distribution
Part of a larger recall action
This product is one of 2 recalled by Roche Diagnostics Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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