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U.S. Department of Health and Human Services

Enforcement Report - Week of August 28, 2013

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Event Detail

Event ID 65507
Product Type Biologics
Status Ongoing
Recalling Firm Life Technologies Holdings Pte Ltd
City Singapore
State
Country SG
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-06-20
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern DE,. IL, MA, MN,NE, OR.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Applied BioSystems (AB) Hi-Di Formamide, 5 ml used with the Hi-DI Formamide 3500 Dx Series. In-Vitro Diagnostic Part Number: 4404307 Lot Number: 1302029 Class III Injection solvent for use with genetic analyzers, stored in warehouse at improper temperatures, was distributed. 1 Bottle B-2151-13
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