Reported Feb 6, 2019 · Terminated
Alinity i Processing Module, (a) Part Number 03R65-01 (b) Part Number A-30108552-01 (c) Part Number A-30109694-01…
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?
- Alinity i Processing Module, (a) Part Number 03R65-01 (b) Part Number A-30108552-01 (c)
- Part Number A-30109694-01 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
- (a)
- Serial NumbersAi01001 - Ai01455, Ai01457, Ai01459 (b) all Serial Numbers (c) all Serial Numbers
- Amount recalled
- 434 units
Why it was recalled
Abbott has identified an issue with the Alinity i Gear Pump Assembly (part number A 30108552 01) resulting in foaming/bubbling out of the bottle reservoir for Concentrated Wash Buffer and an unexpected amount of dried residue of buffer. The foaming/bubbling is a result of an improper calibration of the pump s operating speed.
This product could cause temporary or reversible health problems — stop using it.
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