Medical Device Recall: Z-0007-05

FDA Recalls dataset · Firm: Dade Behring Inc. Rte 896, Glasgow Business Community · Status: Terminated

Recall Action Class: N/A Date Initiated: 2004-07-21 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0007-05.

Recall Res Number
Z-0007-05
FEI Number
2517506
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2004-07-21
Date Posted
2004-10-05
Date Terminated
2004-12-15
Product Code
GJA
Event Number
29987
Product Quantity
3942 kits
Product Description BC Thrombin Reagent . Thrombin Time Test
Reason for Recall The product does not demonstrate the expected prolonged thrombin times for specimens obtained from patients recieving heparin
Action Details The recalling firm issued a recall letter dated 7/21/04 to their accounts informing them of the problem and the need to discard the product.
Distribution Pattern The products were shipped to medical facilities in CT, FL, IA, IL, NJ, PA, and WI. The products were also shipped to Austria, Bosnia, Croatia, Hungry, Germany, Poland, Spain, RussiaFrance, Italy, Australia, Brazil, Canada, Saudi Arabia, El Salvador, and Turkey.
Code Information / Serial Numbers Lot 540624, Lot 540625, and Lot 540626

Related Establishments / Registrations

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