ARCHITECT c8000 System List Number 01G06-98 Product Usage: The Abbott ARCHITECT cSystem is intended for In Vitro diagnos
FDA device recall Z-2202-2015 · posted 2015-07-22 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories
- Reason for recall
- The ARCHITECT c8000 instrument contains tubing that does not meet specifications and has the potential to leak.
- Action taken
- Abbott notified thier affected consignees via phone or visit on 5/29/15. A follow up Product Recall notification letter dated June 4, 2015 was sent to affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to immediately discontinue use of the product, Abbott representative will be make all necessary arrangements for replacing your impacted instruments(s), follow your laboratory protocol regarding the need to review previously reported patient results and retain this notification for laboratory records. For questions contact Customer Service at 1-877-4ABBOTT.
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 5 units
- Distribution
- US Nationwide Distribution in the states of CA, AL, NY and WI.
- Date initiated
- 2015-06-11
- Date posted
- 2015-07-22
- Date terminated
- 2016-02-09
- Location
- Abbott Park, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AEROSET SYSTEM (K980367) | Abbott Laboratories | 1998-04-01 |