Reported Apr 24, 2019 · Terminated
Abbott Alinity i Processing Module LN 03R65-01 - Product Usage: The Alinity i processing module is a fully automated…
Abbott GmbH & Co. KG
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 Gmbh & Co. KG · Max-Planck-Ring 2 · Wiesbaden, N/A · N/A
Is this the product you have?
- Abbott Alinity i Processing
- Module LN 03R65-01 - Product UsageThe Alinity i processing module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology. CMIA technology is used to determine the presence of antigens, antibodies, and analytes in samples
- Lot codes and dates
1,448 of 1,448 codes
AI01015AI01100AI01149AI01180AI01246AI01292AI01335AI01376AI01020AI01101AI01150AI01181AI01249AI01293AI01336AI01377AI01025AI01102AI01151Ai01182AI01252AI01294AI01337AI01378AI01027AI01103AI01152AI01183AI01253AI01295AI01338AI01379AI01032AI01104AI01153AI01184AI01254AI01296AI01339AI01380AI01036AI01105AI01154AI01185AI01255AI01297AI01340AI01381AI01054AI01109AI01155AI01187AI01256AI01298AI01341AI01382AI01055AI01110AI01156AI01188
- Amount recalled
- 1097
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
The safety interlock covering the septum piercing probes within the bulk solution bottle holder may not deploy when a bulk solution bottle is removed from the Alinity ci series and Alinity s System.
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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