FDA Device Recall Z-0008-06: Abbott Laboratories, Inc

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0008-06.

Recall Res Number

Z-0008-06

Recalling Firm / Manufacturer

Abbott Laboratories, Inc

FEI Number

1628664

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2005-02-28

Date Posted

2005-10-06

Date Terminated

2005-11-03

Product Code

JJE

Event Number

33432

Product Quantity

1,107 units worldwide

Product Description ARCHITECT c800 for Conventional Units and for SI Units, Version 5.00.

Reason for Recall Device has incorrect notation associated with therapeutic drug monitoring assays.

Action Details Firm sent device correction letters to consignees on 2/28/2005.

Distribution Pattern California, Louisiana, Massachusetts, North Carolina, Missouri, Oklahoma, Texas, Illinois, Minnesota, South Dakota, North Dakota and Arizona. Foreign countries: Mexico, Columbia, Chile, Canada, Germany, Singapore, China, Australia, and New Zealand

Code Information / Serial Numbers List number 08G98-07 for Conventional Units; List number 04J62-07 for SI Units.

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Medical Device Recall: Z-0008-06

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer