FDA Device Recall Z-0069-2012: Siemens Healthcare Diagnostics, Inc.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0069-2012.

Recall Res Number

Z-0069-2012

Recalling Firm / Manufacturer

Siemens Healthcare Diagnostics, Inc.

FEI Number

2517506

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2011-08-31

Date Posted

2011-10-19

Date Terminated

2014-01-14

Product Code

JJE

Event Number

59889

Product Quantity

6,072 cartons

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

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

Action Details 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.

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

Code Information / Serial Numbers Lot Numbers ED2098, EA2111, FB2134, ED2147

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Medical Device Recall: Z-0069-2012

Recall Parameters & Description

Related Establishments / Registrations

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