FDA Medical Device Recalls (openFDA)
Abbott Laboratories, Inc: Clinical Chemistry Alkaline Phosphatase, List Number 7D55-21 & 7D55-31. Used for the quantitation of alkaline phosphatase in human serum or plasma.
- Recall number
- Z-3278-2011
- Recalling firm
- Abbott Laboratories, Inc
- Product
- Clinical Chemistry Alkaline Phosphatase, List Number 7D55-21 & 7D55-31. Used for the quantitation of alkaline phosphatase in human serum or plasma.
- Status
- Terminated
- Initiated
- 2011-08-26
- Posted
- 2011-09-26
- Terminated
- 2012-08-17
- Reason
- The reagent has the potential to be contaminated with mold, the Cladosporium fungal species.
- Root cause
- 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
- 6269 units
- Distribution
- Worldwide Distribution
- Lot, serial or model codes
- 71628UN10, Exp. 11/19/2011; 62474UN10, Exp. 11/19/2011; and 08145UN11, Exp. 2/15/2012.
- 510(k) numbers
- ["K981806"]
- PMA numbers
- not on file
- Product code
- CJE
- Firm FEI
- 1628664
- Firm city
- Irving
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28