Z-0722-2007

Clinical Chemistry Phosphorus in vitro diagnostic, List Number: 7D71-30 and 7D71-20

Name: Z-0722-2007 Clinical Chemistry Phosphorus in vitro diagnostic, List Number: 7D71-30 and 7D71-20
Creator: Abbott Laboratories Inc.
Published: 2007-01-30
License: https://open.fda.gov/license/

Abbott Medical / initiated 2007-01-30 / Terminated

FDA source

Abbott Laboratories Inc. began a recall of Clinical Chemistry Phosphorus in vitro diagnostic, List Number: 7D71-30 and 7D71-20 on 2007-01-30. The reason FDA records is "Patient results are falsely decreased by up to 15% at these levels: 1) Serum Plasma phosphorus greater than 8.0 mg/dL (2.60 mmol/L) 2) Urine phosphorus greater than 80.0 mg/dL (25.80 mmol/L)". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0722-2007
Status: Terminated
Initiated: 2007-01-30
Posted: 2007-04-05
Terminated: 2011-08-10
Recalling firm: Abbott Medical
Product: Clinical Chemistry Phosphorus in vitro diagnostic, List Number: 7D71-30 and 7D71-20
Product code: CEO Phosphomolybdate (Colorimetric), Inorganic Phosphorus
Reason for recall: Patient results are falsely decreased by up to 15% at these levels: 1) Serum Plasma phosphorus greater than 8.0 mg/dL (2.60 mmol/L) 2) Urine phosphorus greater than 80.0 mg/dL (25.80 mmol/L)
FDA root cause: Other
Action: A Product Correction letter dated January 30, 2007 provided to all Clinical Chemistry Phosphorus customers that have received lot numbers 42020HW00 and 44037HW00 stating that patient results are falsely decreased by up to 15% at these levels: Serum/Plasma phosphorus greater than 8.0 mgldL (2.60 mmol/L) and Urine phosphorus greater than 80.0 mg/dl. (25.80 mmol/L). Modified linearity ranges are provided in the letter that are to be implemented when using the two lots. Instructions are also provided for changing the linearity range on the Architect cSystem as well as the Aeroset System. Customers are instructed that If they have forwarded any of Information the Clinical Chemistry Phosphorus lots listed above to another laboratory to provide a copy of this letter to them. A customer response form is provided.
Quantity in commerce: 42020HW00 - 1,351 units worldwide; 44037HW00 - 314 units worldwide
Distribution: Worldwide, including USA, Canada, Trinidad & Tobago, Bahamas, Panama, Cayman Islands, Jamaica
Product codes and lots: 42020HW00 & 44037HW00

Product code CEO

K981759Class IPhosAbbott Laboratories / cleared 1998-06-16

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)