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Terminated

Dimension LIP Flex Reagent Cartridge, Catalog# DF55A

FDA Recall Z-0588-2011 · Posted 2010-12-10

Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusTerminated
Product CodeCHI
Date Initiated2010-03-10
Date Terminated2011-08-04
Product Quantity21171

Reason for Recall

Open Well instability: After calibration, QC shifts high (out of range) after the Flex Well is hydrated. Shifts of up to 20% have been observed in both QC and patient samplesas soon as two hours post hydration.

Firm Action

Recalling firm issued "Urgent Field Safety Notice", dated March 2010, informing users of the problem and to transition to the revised Lipasae method.

Root Cause

Other

Distribution Pattern

Nationwide Distribution throughout the US.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K952816LIPASE FLEX REAGENT CARTRIDGEDupont Medical Products · 1995-07-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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