Z-0454-2007

Phenobarbital- Reagent-Clinical Chemistry--List number: 1E08-20-Abbott Diagnostics Division

Name: Z-0454-2007 Phenobarbital- Reagent-Clinical Chemistry--List number: 1E08-20-Abbott Diagnostics Division
Creator: Abbott Laboratories Inc.
Published: 2006-09-26
License: https://open.fda.gov/license/

Abbott Medical / initiated 2006-09-26 / Terminated / root cause: manufacturing process

FDA source

Abbott Laboratories Inc. began a recall of Phenobarbital- Reagent-Clinical Chemistry--List number: 1E08-20-Abbott Diagnostics Division on 2006-09-26. The reason FDA records is "Erratic elevated results and or the inability to calibrate due to imprecision". 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-0454-2007
Status: Terminated
Initiated: 2006-09-26
Posted: 2007-01-09
Terminated: 2011-06-14
Recalling firm: Abbott Medical
Product: Phenobarbital- Reagent-Clinical Chemistry--List number: 1E08-20-Abbott Diagnostics Division
Product code: DLZ Enzyme Immunoassay, Phenobarbital
Reason for recall: Erratic elevated results and or the inability to calibrate due to imprecision.
Root cause tag: manufacturing process
FDA root cause: Other
Action: Abbott sent out a product recall letter on 9/26, 2006, to all consignees that received lot numbers 39074HW00, 41008HW00 and 42063HW00. The letter states that the firm has identified a Phenobarbital performance issue that is demonstrated by erratic elevated results and/or the inability to calibrate due to imprecision. Until the cause of this issue is identified, they have discontinued shipment of Phenobarbital reagent. It will be necessary to identity an alternate means for Phenobarbital testing during this time. AXSYM and TDxITDxFLx Phenobarbital are available as alternate testing options (consignee may contact the local sales person or Customer Service). Consignees also advised if they forwarded any of the Clinical Chemistry Phenobarbital lots listed above to another laboratory to provide a copy of the letter to their customer. If there are questions, they are advised to call Customer Service (US consignee) or local sales person (foreign consignee). Letter advises if user currently using or have inventory of lot number 39074HW00, expiration 9/30/06, to run two levels of quality control (QC) every 6 hours and be alert to QC trends. For those using or have inventory of lot numbers 41008HW00 & 42063HW00, they are advised to discontinue use of these lots and destroy them following laboratory procedures. Abbott will provide reimbursement for the destroyed kits. A customer reply form is provided.
Quantity in commerce: Worldwide: Lot #41008HW00 - 162 kits; Lot #42063HW00 - 136 kits; Lot #39074HW00 - 150 Kits
Distribution: Worldwide distribution ---- USA and countries of of Canada, Chile, Germany, Australia
Product codes and lots: 39074HW00 (exp. 9/30/06), 41008HW00 (exp. 10/31/06), 42063HW00 (exp. 12/31/06)

Product code DLZ

K993031Class IIAbbott Aeroset Phenobarbital Assey and Calibrators;models 1E08 and 5F54Syva Co. / cleared 2000-01-27

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)