Clinical Chemistry Alkaline Phosphatase, List Number 7D55-21 & 7D55-31. Used for the quantitation of alkaline phosphatas

FDA device recall Z-3278-2011 · posted 2011-09-26 · Terminated

Recall details

Recalling firm

Abbott Laboratories, Inc

Reason for recall

The reagent has the potential to be contaminated with mold, the Cladosporium fungal species.

Action taken

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.

Root cause

Pending

Status

Terminated

Product code

CJE

Quantity affected

6269 units

Distribution

Worldwide Distribution

Date initiated

2011-08-26

Date posted

2011-09-26

Date terminated

2012-08-17

Location

Irving, TX

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