Recall Z-1118-2013— Abbott Laboratories, Inc

Name: FDA recall Z-1118-2013
Creator: U.S. Food and Drug Administration
Published: 2012-11-16

Class II · Terminated

Class II FDA medical device recall by Abbott Laboratories, Inc, initiated 2012-11-16, terminated 2013-06-18. It names one FDA 510(k) clearance: K993031. Product: Clinical Chemistry Phenobarbital, list number 1E08. Reason: 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.

Recalling firm: Abbott Laboratories, Inc
Classification: Class II
Status: Terminated
Initiated: 2012-11-16
Terminated: 2013-06-18
Firm location: Irving, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K993031 — ABBOTT AEROSET PHENOBARBITAL ASSEY AND CALIBRATORS; MODELS 1E08 AND 5F54Syva Co.·cleared 2000-01-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Clinical Chemistry Phenobarbital, list number 1E08

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.