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U.S. Department of Health and Human Services

Enforcement Report - Week of October 17, 2012

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Product Detail

Product Description Associates of Cape Cod Pyrotell Limulus Amebocyte Lysate (LAL) . In vitro diagnostic use to detect and quantify endotoxin gel-clot method Catalog Number: G5250-5: 5 vial Packs; Catalog Number: G5250-25: 25 vial Packs
Recall Number B-2565-12
Classification Class III
Code Info Lot number: 51006539
Product Distributed Qty 217 (5 vial Packs) and 37 (25 vial Packs)
Reason For Recall One lot of mislabeled Pyrotell gel clot LAL reagent was distributed.

Event Detail

Event Id 62969
Product Type Biologics
Status Ongoing
Recalling Firm Associates of Cape Cod, Inc.
City East Falmouth
State MA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-06-25
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern CA, IA, FL, MN, NC, NY, SC, TX Foreign: Canada, Columbia, Brazil, Ecuador, Guatemala, Hong Kong, Indonesia, Korea, Russian Federation, UK, Taiwan