Overview of recall records associated with Abbott Molecular, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 19, Class I: 5, Class III: 3.
There were reports of an increase in reactive negative controls and false positive results.
There were reports of an increase in reactive negative controls and false positive results.
The design of the Alinity m System Solutions drawer enclosure may allow liquid (liquid waste or system solutions) originating in the System Solutions drawer to flow beyond the footprint of…
Abbott has identified an increase of incidences regarding Error Code (EC) 9198 (Positive control is non-reactive) while using the Alinity m HR HPV AMP Kit and Alinity m STI AMP Kit. Certain…
Abbott has identified an increase of incidences regarding Error Code (EC) 9198 (Positive control is non-reactive) while using the Alinity m HR HPV AMP Kit and Alinity m STI AMP Kit. Certain…
The Alinity m System camera detects whether tubes are "capped." If the camera detects a cap and the retention bar is not present on the sample rack, the system will generate the message…
Products that were intended for export only which were not approved or registered in accordance with U.S. specifications were shipped to U.S. customers.
Products that were intended for export only which were not approved or registered in accordance with U.S. specifications were shipped to U.S. customers.
Products that were intended for export only which were not approved or registered in accordance with U.S. specifications were shipped to U.S. customers.
Abbott has received reports of an increase in reactive negative controls and false positive results in patient samples when using the Identified Lots of Alinity m HCV AMP Kit.
The instrument was found to be installed without plunger assemblies in the clamp bar for an Amplification Detection Unit. After correction of the issue, the instrument was returned for use…
The firm identified the following three potential issues which may have impacted ADUs installed on distributed Alinity m Systems. 1. Systems which had their ADUs serviced may have an…
Abbott has identified potential performance issues for the Alinity m System software version 1.6.5: 1) In a unique scenario, the waste chute flapper was found to not open when the Systems…
Reports received of an increase of message code 9186 (internal control failed) when using the kit.
There is a potential for misquantitation high results for negative samples.
There is a potential for misquantitation high results of negative samples.
There is potential for the Reaction Vessels (RVs) detaching from the RV cap during transport by the pipettor robot.
There is a potential for abnormal (non-sigmoidal) amplification curves.
There is a software issue associated with the ability to properly complete a Field Service Engineer Maintenance and Diagnostics procedure.
There is a software defect that can cause the Amplification Detection clamp CLEAN position to be set too high.
There is an issue with the installation of updated camera firmware on the system.
There is a potential for false positive results.
There is a potential for false positive results.
There is a potential for false positive results.
This page summarizes recall records in which the official source identifies Abbott Molecular, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.
