Clinical Chemistry Alkaline Phosphatase, List Number 7D55-21 & 7D55-31. Used for the quantitation of alkaline phosphatase in human serum or plasma.
This recall has been terminated (originally issued September 26, 2011).
- Company
- Abbott Laboratories, Inc
- Recall Initiated
- August 26, 2011
- Posted
- September 26, 2011
- Terminated
- August 17, 2012
- Recall Number
- Z-3278-2011
- Quantity
- 6269 units
- Firm Location
- Irving, TX
- Official Source
- View on FDA website ↗
Reason for Recall
The reagent has the potential to be contaminated with mold, the Cladosporium fungal species.
Distribution
Worldwide Distribution
Lot / Code Info
71628UN10, Exp. 11/19/2011; 62474UN10, Exp. 11/19/2011; and 08145UN11, Exp. 2/15/2012.
Root Cause
Pending
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.