Z-3278-2011

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

Name: Z-3278-2011 Clinical Chemistry Alkaline Phosphatase, List Number 7D55-21 & 7D55-31. Used for the quantitation of alkaline...
Creator: Abbott Laboratories, Inc
Published: 2011-08-26
License: https://open.fda.gov/license/

Abbott Medical / initiated 2011-08-26 / Terminated

FDA source

Abbott Laboratories, Inc began a recall of Clinical Chemistry Alkaline Phosphatase, List Number 7D55-21 & 7D55-31. Used for the quantitation of alkaline phosphatase in human serum or plasma on 2011-08-26. The reason FDA records is "The reagent has the potential to be contaminated with mold, the Cladosporium fungal species". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-3278-2011
Status: Terminated
Initiated: 2011-08-26
Posted: 2011-09-26
Terminated: 2012-08-17
Recalling firm: Abbott Medical
Product: Clinical Chemistry Alkaline Phosphatase, List Number 7D55-21 & 7D55-31. Used for the quantitation of alkaline phosphatase in human serum or plasma.
Product code: CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Reason for recall: The reagent has the potential to be contaminated with mold, the Cladosporium fungal species.
FDA 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 in commerce: 6269 units
Distribution: Worldwide Distribution
Product codes and lots: 71628UN10, Exp. 11/19/2011; 62474UN10, Exp. 11/19/2011; and 08145UN11, Exp. 2/15/2012.

Product code CJE

K981806Class IIAlkpAbbott Laboratories / cleared 1998-06-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)