|
Class 2 Device Recall ARCHITECT c4000 Cuvette Segment |
|
Date Initiated by Firm |
December 08, 2017 |
Date Posted |
January 18, 2018 |
Recall Status1 |
Terminated 3 on July 11, 2019 |
Recall Number |
Z-0921-2018 |
Recall Event ID |
78838 |
510(K)Number |
K980367
|
Product Classification |
Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
|
Product |
ARCHITECT c4000 Cuvette Segment, Part #02P75-01/02P24, a component to the ARCHITECT Clinical Chemistry system. There are 9 segments with each cuvette segment holding 11 cuvettes for a total of 99 cuvettes per reaction carousel. The firm name on the label is Abbott Laboratories, Abbott Park, IL.
The Abbott ARCHITECT Clinical Chemistry Systems are designed to perform automated chemistry tests utilizing photometry and potentiometric technology. The cuvette segments are a component of the system and are racks that sit in the reaction carousel and hold cuvettes. |
Code Information |
All serial numbers |
Recalling Firm/ Manufacturer |
Abbott Laboratories, Inc 1921 Hurd Dr Irving TX 75038-4313
|
For Additional Information Contact |
Albert Chianello 877-422-2688
|
Manufacturer Reason for Recall |
There is a potential to generate falsely depressed patient results in the cuvettes adjacent to the detached segment post for any assay run on the c4000, c8000, and c16000 instrument.
|
FDA Determined Cause 2 |
Device Design |
Action |
The firm, Abbott Laboratories, issued a "Product Correction" letter dated 12/8/2017 via overnight mail on 12/8/2017 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to adhere to the new instructions listed in Appendix A to avoid damaging the cuvette segments; If a cuvette segment with a detached bottom is identified, replace it before performing any additional testing on your ARCHITECT Clinical Chemistry System; If you have forwarded the product listed above to other laboratories, please inform them of this Product Correction and provide to them a copy of this letter and retain this letter for your laboratory records.
The procedures will be updated in a future version of the ARCHITECT Operations Manual.
If you or any of the health care providers you serve have any questions regarding this information, U.S. Customers please contact Customer Service at 18774ABBOTT (available 24 hours a day, 7 days a week). Customers outside the U.S., please contact your local area Customer Service. |
Quantity in Commerce |
3,634 ARCHITECT c4000 systems |
Distribution |
Worldwide Distribution: US (nationwide) including Puerto Rico and countries of: Afghanistan, Albania, Algeria, Angola, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahamas, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Brunei, Bulgaria, Burkina Faso, Cameroon, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Curacao, Cyrus, Czech Republic, Dem Rep of The Congo, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Finland, France, Gaza & Jericho, Georgia, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Ivory Coast, Jamaica, Jordan, Kazakhstan, Kenya, Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malawi, Malaysia, Maldives, Mali, Mauritania, Mexico, Moldova, Montenegro, Montserrat, Morocco, Netherlands, New Zealand, Nigeria, North Yemen, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia (CIS), Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, St. Lucia, St. Vincent, Sweden, Switzerland, Taiwan, Tajikistan, Tanzania, Thailand, Trinidad & Tobago, Tunisia, Turkey, UAE, Uganda, United Kingdom, Uruguay, Venezuela, Vietnam, Zambia and Zimbabwe. . |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = JJE and Original Applicant = ABBOTT LABORATORIES
|
|
|
|