Z-2398-2010

Clinical Chemistry Phosphorus assay

Name: Z-2398-2010 Clinical Chemistry Phosphorus assay
Creator: Abbott Laboratories Inc.
Published: 2010-05-04
License: https://open.fda.gov/license/

Abbott Medical / initiated 2010-05-04 / Terminated / root cause: manufacturing process

FDA source

Abbott Laboratories Inc. began a recall of Clinical Chemistry Phosphorus assay on 2010-05-04. The reason FDA records is "Product may give inaccurate results and aspiration errors with reagent configuration, including results outside of linear range & calibration failure". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2398-2010
Status: Terminated
Initiated: 2010-05-04
Posted: 2010-09-10
Terminated: 2012-04-05
Recalling firm: Abbott Medical
Product: Clinical Chemistry Phosphorus assay
Product code: CEO Phosphomolybdate (Colorimetric), Inorganic Phosphorus
Reason for recall: Product may give inaccurate results and aspiration errors with reagent configuration, including results outside of linear range & calibration failure.
Root cause tag: manufacturing process
FDA root cause: Other
Action: Abbott Laboratories issued a "Product Recall: Immediate Action Required" letter dated May 4, 2010 to consignees. The letter described the product, problem and action to be taken by the customer. The letter instructed the customer to: 1) Identify affected product in inventory 2) Discontinue use and destroy any remaining inventory of the affected lot: 7D71-21 3) Complete and return an enclosed Customer Reply Form 4) Order alternative kit sizes for Clinical Chemistry Phosphorus: LN 7D71-31 or 7D71-22 5) For AEROSET Systems, manually update parameters as described in the letter. 6) For ARCHITECT cSystems, implement alternative kit sizes without system changes. 7) Provide a copy of the letter to other laboratories that have been distributed the affected product. US customers can contact Abbott Customer Service at 1-877-4ABBOTT. Customers outside the U>S> are instructed to contact their local area Customer Service.
Quantity in commerce: 3136
Distribution: Worldwide Distribution: US, including Puerto Rico, and countries of Germany, New Zealand, Trinidad/Tobago, Cayman Island, Hong Kong, Chile, Curacao, Jamaica, Australia, and Bahamas.
Product codes and lots: Lot number: 81040HW00; expires July 15, 2010, 85009HW00; expires December 15th, 2010. (All Lots of Clincal Phosphorous LN 7D71-21).

Product code CEO

K781000Class IPhosphorus (Inorganic) Analysis ProductsAbbott Laboratories / cleared 1978-12-04

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)