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U.S. Department of Health and Human Services

Class 2 Device Recall Abbott Clinical Chemistry Alkaline Phosphatase Assay

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  Class 2 Device Recall Abbott Clinical Chemistry Alkaline Phosphatase Assay see related information
Date Initiated by Firm August 26, 2011
Date Posted September 26, 2011
Recall Status1 Terminated 3 on August 17, 2012
Recall Number Z-3278-2011
Recall Event ID 59862
510(K)Number K981806  
Product Classification Nitrophenylphosphate, alkaline phosphatase or isoenzymes - Product Code CJE
Product Clinical Chemistry Alkaline Phosphatase, List Number 7D55-21 & 7D55-31.

Used for the quantitation of alkaline phosphatase in human serum or plasma.
Code Information 71628UN10, Exp. 11/19/2011; 62474UN10, Exp. 11/19/2011; and 08145UN11, Exp. 2/15/2012.
Recalling Firm/
Manufacturer		 Abbott Laboratories, Inc
1921 Hurd Drive
PO Box 152020
Irving TX 75038-4313
For Additional Information Contact Mark Littlefield
972-518-6000
Manufacturer Reason
for Recall		 The reagent has the potential to be contaminated with mold, the Cladosporium fungal species.
FDA Determined
Cause 2		 Pending
Action The firm decided to recall and notified consignees by a Product Recall - Immediate Action Required letter on 08/26/11. The letter identified the affected product, the reason for the recall, the patient impact, and necessary actions to be taken by the customer. Customers are to determine if they are using or have the affected product in their inventory. Customers are to discontinue use and destroy any remaining product of the specified lots in accordance with their facility's policies and procedures. Alternative lots of the product should be ordered and the enclosed Customer Reply form should be completed and returned. The letter also states that customers may want to decontaminate their systems by following the steps in Attachment A. If the product from the affected lots were further distributed, a copy of the letter should be provided to those customers as well. Questions regarding the letter should be directed to Customer Service at 1-877-4ABBOTT for US customers, and customers outside of the US should contact their local area Customer Service.
Quantity in Commerce 6269 units
Distribution Worldwide Distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = CJE and Original Applicant = ABBOTT LABORATORIES
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