Roche Diagnostics Corporation recalls cobas p 501 post-analytical units, Part Number 05158494001. For diagnostic sample storage and retrieval.
- Recall date
- April 4, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1927-2019
- FDA classification
- Class III
- Brand / firm
- Roche Diagnostics Corporation
- Sold / distributed
- US Nationwide Distribution in the states of AL, CA, FL, IA, IL, KY, MD, OR & PA
Why it was recalled
There is a potential for the tray input flap on the post analytical units to become loose, potentially detaching from the instrument.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
cobas p 501 post-analytical units, Part Number 05158494001. For diagnostic sample storage and retrieval.
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