FDA Device Recall Z-0025-2007: Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0025-2007.

Recall Res Number

Z-0025-2007

Recalling Firm / Manufacturer

Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila

FEI Number

2623532

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2006-09-07

Date Posted

2006-10-12

Date Terminated

2011-09-09

Product Code

JIT

Event Number

36405

Product Quantity

624

Product Description Architect FSH Calibrators (LN 6C24-01), for in vitro diagnostic use.

Reason for Recall Following a customer complaint, Abbott found an atypical stability profile for the lot of the calibrators listed in this recall. The investigation to date has shown that both controls and patient results have shifted upwards over time together.

Action Details The Device Recall Letter dated September 07, 2006, and Customer Reply Form was sent via Federal Express Priority mail to all customers who received the affected lots.

Distribution Pattern Worldwide, including USA, Puerto Rico, Canada, Mexico, Guatemala, Costa Rica, Venezuela, Colombia, Ecuador, Chile, Uruguay, Argentina, Brazil, Dominican Republic, El Salvador, Germany, Japan, Singapore, Hong Kong, Taiwan, Thailand, South Korea, Australia, Honduras, Trinidad-Tobago, St. Vincent, Bahamas, Panama, and Cayman Islands.

Code Information / Serial Numbers Lot # 33363Q100 Expiration Date 11/04/2006

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Medical Device Recall: Z-0025-2007

Recall Parameters & Description

Related Establishments / Registrations

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