Abbott Laboratories, Inc: Medical Device Recall in 2013 - (Recall #: Z-1118-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

Clinical Chemistry Phenobarbital, list number 1E08

Product Classification:

Class II

Date Initiated: November 16, 2012

Date Posted: April 24, 2013

Recall Number: Z-1118-2013

Event ID: 63945

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

Status: Terminated

Product Quantity: 1289

Code Information:

Lot Numbers 52803UN12, 62299UN12, and 85773UN12

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated