Z-1118-2013Class II

Clinical Chemistry Phenobarbital, list number 1E08

Name: Z-1118-2013 Clinical Chemistry Phenobarbital, list number 1E08
Creator: Abbott Laboratories, Inc
Published: 2012-11-16
License: https://open.fda.gov/license/

Abbott Medical / initiated 2012-11-16 / Terminated / root cause: manufacturing process

FDA source

Abbott Laboratories, Inc began a recall of Clinical Chemistry Phenobarbital, list number 1E08 on 2012-11-16. FDA classified it as Class II and gives the reason as "Abbott Diagnostics is recalling Clinical Chemistry Phenobarbital reagent lots 62299UN12 and 85773UN12 due to imprecision issues which increase with the age of the reagent lot. The imprecision of the Phenobarbital assay...". 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-1118-2013
Classification: Class II
Status: Terminated
Initiated: 2012-11-16
Posted: 2013-04-15
Terminated: 2013-06-18
Recalling firm: Abbott Medical
Product: Clinical Chemistry Phenobarbital, list number 1E08
Product code: DLZ Enzyme Immunoassay, Phenobarbital
Reason for recall: Abbott Diagnostics is recalling Clinical Chemistry Phenobarbital reagent lots 62299UN12 and 85773UN12 due to imprecision issues which increase with the age of the reagent lot. The imprecision of the Phenobarbital assay is d 7% Total CV%; however, internal testing confirmed CVs up to approximately 12% for in-date reagent lots over five months old. Although lot 52803UN12 is now expired, it exhibit
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Abbott Laboratories sent an Immediate Action Required Product Recall letter dated November 16, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use and destroy any remaining inventory of the affected product in accordance with their institution's policies and procedures, order replacement lot 27426UN12 which will expire 18 DEC 2012, and is the only lot currently available (Additional lots will be available in December and January), and complete and return the enclosed Customer Reply Form. If lots were forwarded to another laboratory, a copy of the letter should be forwarded to them. For questions regarding this recall call 1-877-4ABBOTT. For customers outside of the US they should contact their local area Customers Service.
Quantity in commerce: 1289
Distribution: Worldwide Distribution - USA (nationwide) and Internationally to Internationally distributed to Argentina, Australia, Austria, Bahamas, Brunei, Canada, Chile, Curacao, Denmark, France, Germany, Greece, Ireland, Italy, Lebanon, Mexico, Netherlands, Norway, Oman, Paraguay, Portugal, Puerto Rico, Russia, Saudi Arabia, Serbia, South Korea, Spain, Switzerland, Turkey, and United Kingdom.
Product codes and lots: Lot Numbers 52803UN12, 62299UN12, and 85773UN12

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1118-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1118-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-24	2013-04-15

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)