FDA Medical Device Recalls (openFDA)
Abbott Laboratories, Inc: Clinical Chemistry Phenobarbital, list number 1E08
- Recall number
- Z-1118-2013
- Recalling firm
- Abbott Laboratories, Inc
- Product
- Clinical Chemistry Phenobarbital, list number 1E08
- Status
- Terminated
- Initiated
- 2012-11-16
- Posted
- 2013-04-15
- Terminated
- 2013-06-18
- 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
- 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
- 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.
- Lot, serial or model codes
- Lot Numbers 52803UN12, 62299UN12, and 85773UN12
- 510(k) numbers
- ["K993031"]
- PMA numbers
- not on file
- Product code
- DLZ
- Firm FEI
- 1628664
- Firm city
- Irving
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28