Clinical Chemistry Phenobarbital, list number 1E08

FDA device recall Z-1118-2013 · posted 2013-04-15 · Terminated

Recall details

Recalling firm

Abbott Laboratories, Inc

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

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

DLZ

Quantity affected

1289

Distribution

Worldwide Distribution - USA (nationwide) and Internationally to Internationally distributed to Argentina, Australia, Austria, Bahamas, Brunei, Canada, Chile, Curacao, Denmark, France, Germany, Greece

Date initiated

2012-11-16

Date posted

2013-04-15

Date terminated

2013-06-18

Location

Irving, TX

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