Reported Jul 10, 2019 · Terminated
cobas p 701 post-analytical units, Part Number 05349966001. For diagnostic sample storage and retrieval.
Roche Diagnostics Corporation
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Roche Diagnostics Corporation · 9115 Hague Rd · Indianapolis, IN · 46256-1025
Is this the product you have?
- cobas p 701 post-analytical units, Part Number 05349966001. For diagnostic sample storage and retrieval.
- Lot codes and dates
Serial Numbers - 1001 through 1037and 502
- Amount recalled
- 9 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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