Architect C4000 recall
ARCHITECT c4000 part number 02P24; ARCHITECT c8000 part number 01G06; ARCHITECT c16000 part number 03L77 Clinical Chemistry systems.
Why was Architect C4000 recalled?
The Peristaltic Head tubing placed on the ARCHITECT c4000, c8000, and c16000 has the possibility to leak due to a manufacturing issue associated with the tubing connector.
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?
c400073, c400103, c400498, c400600, c400890, c400934, c400935, c401018, c401055, c401056, c401182, c401505, c401520, c401686, c401887, c460196, c460200, c460943, c461550, c803669, c803753, c1600144, c1600249, c1600251, c1600641, c1600720, c1600819, c1600859, c1600976, c1601350, c1601351
- Product
- ARCHITECT c4000 part number 02P24; ARCHITECT c8000 part number 01G06; ARCHITECT c16000 part number 03L77 Clinical Chemistry systems.
- Recalling firm
- Abbott Laboratories, Inc
- Quantity
- 34 units
- Distribution
- Worldwide distribution to US, Canada, France, and Germany.
- Recall date
- November 29, 2017
- Classification
- Class II
- Status
- Completed
- Agency
- FDA (device)