AB Sciex Triple Quad 4500MD LC/MS/MS System, Part No. 5031257; and QTRAP 4500MD LC/MS/MS System, Part No. 5031231. Mass spectrometers for in vitro diagnostic use only.
FDA Recall Z-1671-2016 · Posted None
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Recalling FirmAb Sciex
Recall StatusTerminated
Product CodeDOP
Date Initiated2016-03-25
Date Terminated2016-05-23
Product Quantity2 units
Reason for Recall
Under certain conditions, mass spectrometers may report incorrect quantitative results.
Firm Action
AB SCIEX issued Urgent: Medical Device Correction letter, dated 3/25/16, advising user of the problem and advising not to use the system until corrected. The letter also discussed the risk to health, as well as how to recognize if the issue has occurred. Sciex Field Service Employee (FSE) will be sent to customer site to perform the field corrective action on the affected system. Questions regarding the letter should be directed to SCIEX at 1-289-982-2531.
Root Cause
Under Investigation by firm
Distribution Pattern
Distributed to the state of NC.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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