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Terminated

Siemens Healthcare Diagnostics, Inc. Dimension(R) EXL Cardiac Troponin I Flex(R) Reagent Cartridges

FDA Recall Z-0069-2012 · Posted 2011-10-19

Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusTerminated
Product CodeJJE
Date Initiated2011-08-31
Date Terminated2014-01-14
Product Quantity6,072 cartons

Reason for Recall

Firm has confirmed customer complaints for low recovery of QC and patient samples.

Firm Action

Siemens Healthcare Diagnostics, Inc. Urgent Field Safety Notice was sent to customers on August 31, 2011 regarding the issue. The letter instructs customers to immediately discontinue use of the affected lots and discard all remaining inventory.

Root Cause

Process control

Distribution Pattern

Worldwide distribution: USA, Puerto Rico, Guam, Austria, Canada, Croatia, France, Greece, Germany, Italy, Japan, Mexico, Portugal, Spain and Switzerland.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K081643DIMENSION TNI FLEX REAGENT CARTRIDGE, AND CTNI SAMPLE DILUENT WITH MODELS, RF621, KD692Siemens Healthcare Diagnostics · 2008-07-03

Official Source

View FDA Recall →

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

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