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

    • AI01015
    • AI01100
    • AI01149
    • AI01180
    • AI01246
    • AI01292
    • AI01335
    • AI01376
    • AI01020
    • AI01101
    • AI01150
    • AI01181
    • AI01249
    • AI01293
    • AI01336
    • AI01377
    • AI01025
    • AI01102
    • AI01151
    • Ai01182
    • AI01252
    • AI01294
    • AI01337
    • AI01378
    • AI01027
    • AI01103
    • AI01152
    • AI01183
    • AI01253
    • AI01295
    • AI01338
    • AI01379
    • AI01032
    • AI01104
    • AI01153
    • AI01184
    • AI01254
    • AI01296
    • AI01339
    • AI01380
    • AI01036
    • AI01105
    • AI01154
    • AI01185
    • AI01255
    • AI01297
    • AI01340
    • AI01381
    • AI01054
    • AI01109
    • AI01155
    • AI01187
    • AI01256
    • AI01298
    • AI01341
    • AI01382
    • AI01055
    • AI01110
    • AI01156
    • AI01188
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.

Want the full recall guide?

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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Sep 28, 2022 · Data as of Sep 19, 5:36 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.