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U.S. Department of Health and Human Services

Enforcement Report - Week of October 17, 2012

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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
Distribution Pattern CA, IA, FL, MN, NC, NY, SC, TX Foreign: Canada, Columbia, Brazil, Ecuador, Guatemala, Hong Kong, Indonesia, Korea, Russian Federation, UK, Taiwan

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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 Lot number: 51006539 Class III One lot of mislabeled Pyrotell gel clot LAL reagent was distributed. 217 (5 vial Packs) and 37 (25 vial Packs) B-2565-12