Reported Apr 30, 2025 · Ongoing
Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-10 Software Version: All software…
Abbott Laboratories
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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: Abbott Laboratories · 100 Abbott Park Rd Bldg Ap8b · Abbott Park, IL · 60064-3502
Is this the product you have?
- Brand NameCELL-DYN
- Ruby Product NameCELL-DYN
- Ruby Model/Catalog Number08H67-10
- Software VersionAll
- software versions Product DescriptionCELL-DYN
- Ruby ComponentNo
- Lot codes and dates
- UDI-DI 00380740017170 SNs
35405BG36034BG36259BG36326BG36327BG36328BG36372BG36545BG36556BG36583BG36588BG36589BG54539BG55361BG55454BG55520BG55814BG55828BG72229BG
- UDI-DI 00380740017170 SNs
- Amount recalled
- 19
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
Why it was recalled
When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of the Operator's Manual.
This product could cause temporary or reversible health problems — stop using it.
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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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