ARCHITECT c4000 Cuvette Segment recall
ARCHITECT c4000 Cuvette Segment, List number 02P75-01. The firm name on the label is Abbott Laboratories, Abbott Park, IL. Cuvette segments are a…
Why was ARCHITECT c4000 Cuvette Segment recalled?
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 instrument.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All c4000s
- Product
- ARCHITECT c4000 Cuvette Segment, List number 02P75-01. The firm name on the label is Abbott Laboratories, Abbott Park, IL. Cuvette segments are a…
- Recalling firm
- Abbott Laboratories, Inc
- Quantity
- 1,385 cuvette segments
- Distribution
- Worldwide Distribution: US (nationwide) including Puerto Rico, and countries of: Algeria, Angola, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahamas, Bangladesh, Belarus, Belgium, Bosnia & Herzegovina, Brazil, Brunei, Bulgaria Burkina Faso, Canada, Chile, China, Columbia, Costa Rica, Croatia, Czech Republic, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Finland, France, Gaza & Jericho, Georgia, Germany, Ghana, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Ivory Coast, Jordan, Kazakhstan, Kenya, Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malawi, Malaysia, Maldives, Mali, Mauritania, Mexico, Morocco, Netherlands, New Zealand, Nigeria, North Yemen, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia (CIS), Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, St. Lucia, Sweden, Switzerland, Tajikistan, Tanzania, Thailand, Trinidad & Tobago, Tunisia, Turkey, Turks & Caicos, UAE, Uganda, United Kingdom, Uruguay, Venezuela, Viet Nam, Zambia, and Zimbabwe.
- Recall date
- October 18, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)