Z-0958-2007

IMx Theophylline Reagent Pack (List 1A81-20) In Vitro test. This reagent system is composed of one bottle of...

Name: Z-0958-2007 IMx Theophylline Reagent Pack (List 1A81-20) In Vitro test. This reagent system is composed of one bottle of...
Creator: Abbott Diagnostic International, Ltd.
Published: 2007-04-11
License: https://open.fda.gov/license/

Abbott Diagnostic International, Ltd. / initiated 2007-04-11 / Terminated / root cause: manufacturing process

FDA source

Abbott Diagnostic International, Ltd. began a recall of IMx Theophylline Reagent Pack (List 1A81-20) In Vitro test. This reagent system is composed of one bottle of Theophylline Pretreatment Solution, one bottle of... on 2007-04-11. The reason FDA records is "A decrease in mP values (calibration curve Net Polarization value) has been observed with this reagent lot at all calibrator levels and may produce the following results: Calibration Error Code 148 (Polarization Too...". 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-0958-2007
Status: Terminated
Initiated: 2007-04-11
Posted: 2007-07-03
Terminated: 2011-06-10
Recalling firm: Abbott Diagnostic International, Ltd.
Product: IMx Theophylline Reagent Pack (List 1A81-20) In Vitro test. This reagent system is composed of one bottle of Theophylline Pretreatment Solution, one bottle of Theophylline Antiserum (Mouse Monoclonal) and one bottle of Theophylline Fluorescein Tracer.
Product code: LER Fluorescent Immunoassay, Theophylline
Reason for recall: A decrease in mP values (calibration curve Net Polarization value) has been observed with this reagent lot at all calibrator levels and may produce the following results: Calibration Error Code 148 (Polarization Too Small), Calibration Error Code 172 (Calibration Not Stored or Calibration Not Accepted) Controls out of range (when using a stored calibration curve).
Root cause tag: manufacturing process
FDA root cause: Other
Action: An April 11, 2007, Product Recall Letter was sent to all customers who received the affected lot. All customers who received the affected lot will be contacted. The following communication types were used: Product Recall Letter & Customer Reply Form. Letters were sent to customers by Federal Express Priority mail. The Customers were instructed the following: To discontinue use of and destroy IMx Theophylline reagent lot 41610QI00. If they had forwarded the lots listed in the Product Recall letter to other laboratories, they were instructed to inform them of this Product Recall and provide a copy of this letter to them. They also we instructed to retain a copy of the communication for their records
Quantity in commerce: 17 Kits
Distribution: Worldwide: CA, IL, MA, NY, OR, PA, VA, and WV and countries of Germany and Singapore
Product codes and lots: Lot #41610Q100; Expiration date 04/25/2008

Product code LER

K833070Class IITdx TheophyllineAbbott Laboratories / cleared 1983-11-14

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)