FDA Medical Device Recalls (openFDA)
Abbott Laboratories: ARCHITECT Reaction Vessel, 2000 units per carton; for in vitro diagnostic use with the ARCHITECT i System; Abbott Laboratories, Abbott Park, IL 60064; list 7C15-01. The ARCHITECT Reaction Vessels are disposable containers in which the Chemiluminescent Microparticle Immunoassay (CMIA) reaction takes place for sample analysis.
- Recall number
- Z-1392-2009
- Recalling firm
- Abbott Laboratories
- Product
- ARCHITECT Reaction Vessel, 2000 units per carton; for in vitro diagnostic use with the ARCHITECT i System; Abbott Laboratories, Abbott Park, IL 60064; list 7C15-01. The ARCHITECT Reaction Vessels are disposable containers in which the Chemiluminescent Microparticle Immunoassay (CMIA) reaction takes place for sample analysis.
- Status
- Terminated
- Initiated
- 2009-02-26
- Posted
- 2009-05-27
- Terminated
- 2010-11-04
- Reason
- Abbott has had an increase in complaints due to the receipt of error code 1006 (unable to process test, background read failure), error code 1007 (unable to process test, activated read failure) and incorrect results when using these lots of ARCHITECT Reaction Vessels.
- Root cause
- Nonconforming Material/Component
- Action
- Consignees were contacted by phone and sent an "Urgent Field Safety Notice Product Recall" dated February 26, 2009. The letter informed users of the problem and detailed how to identify and discard the affected product. In addition, Abbott Laboratories asked the consignees to send a copy of the letter to any laboratory to which they may have forwarded any of affected lots. Abbott sent a second letter dated May 12, 2009 informing consignees of a recall expansion of additional affected lots. The recall was again expanded on 12/17/09 for an addtional 40 lots of reaction vessels. For additional information, contact Abbott Labs at 1-877-4ABBOTT.
- Quantity
- 27,163 cartons
- Distribution
- Nationwide including Puerto Rico, and internationally to Canada, Mexico, Guatemala, Costa Rica, Venezuela, Colombia, Chile, Argentina, Dominican Republic, Honduras, Nicaragua, Germany, Japan, Hong Kong, Taiwan, Thailand, South Korea, Uruguay, Austria, Bahrain, Belarus, Belgium, Bosnia & Herzegovia, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Greece, Hungary, India, Indonesia, Ireland, Italy, Jamaica, Kuwait, Luxembourg, Malaysia, Netherlands, Norway,Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, United Arab Emirates, United Kingdom, Zimbabwe and Australia.
- Lot, serial or model codes
- Product Number: 7C15-01; Lot Numbers: 68446P100, 69061P100, 69283P100, 68487P100, 69063P100, 69284P100, 68488P100, 69082P100, 69340P100, 68489P100, 69176P100, 69341P100, 68491P100, 69177P100, 69342P100, 68492P100, 69178P100, 69353P100, 68511P100, 69179P100, 69433P100, 68513P100, 69180P100, 69434P100, 68515P100, 69205P100, 69435P100, 68516P100, 69206P100, 69436P100, 68553P100, 69207P100, 69438P100, 69006P100, 69208P100, 69439P100, 69007P100, 69209P100, 69521P100, 69008P100, 69266P100, 69522P100, 69009P100, 69267P100, 69523P100, 69010P100, 69280P100, 69526P100, 69058P100, 69281P100, 69527P100, 69060P100, 69282P100 and 69660P100, 68306P100, 68389P100, 68390P100, 68391P100, 68392P100, 68393P100, 69684P100, 73657P100, 73742P100, 74114P100, 74115P100, 74117P100, 74235P100, 74277P100 and 74283P100. The recall was expanded to include an additional 40 lots on 12/7/09: 62616P100, 62756P100, 65386P100, 65388P100, 65740P100, 68007P100, 68097P100, 68119P100, 68241P100, 69683P100, 69686P100, 70421P100, 70431P100, 70563P100, 70565P100, 70598P100, 70601P100, 71077P100, 71092P100, 71168P100, 71234P100, 71235P100, 71239P100, 71304P100, 71447P100, 71448P100, 71450P100, 71451P100, 71515P100, 71519P100, 71550P100, 71554P100, 71555P100, 71558P100, 72252P100, 72293P100, 73319P100, 73464P100, 78387P100, and 80275P100.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JJE
- Firm FEI
- 1415939
- Firm city
- Abbott Park
- Firm state
- IL
- 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