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U.S. Department of Health and Human Services

Enforcement Report - Week of August 28, 2013

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Product Detail

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

Event Detail

Event Id 65507
Product Type Biologics
Status Ongoing
Recalling Firm Life Technologies Holdings Pte Ltd
City Singapore
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.