ARCHITECT Total T3 Reagent Kit (7K64) consists of: - 1 or 4 Bottle(s) (6.6 mL/27.0 mL) anti-T3 (sheep) coated microparti
FDA device recall Z-0474-2015 · posted 2014-12-03 · Terminated
Recall details
- Recalling firm
- Abbott Ireland Diagnostics Division
- Reason for recall
- 17% of ARCHITECT Total T3 Reagent Kit, LN 7K64-20/-25 reagent lots 38901UI00 and 38901UI01 may exhibit lower Relative Light Units (RLUs) than expected, which in turn may result in controls out of range or patient results higher than expected.
- Action taken
- Abbott sent an Product Recall letter dated September 11, 2014, to all direct accounts (customers). The letters included instructions for customers to: 1) Discontinue use of and destroy any remaining inventory according to your laboratory procedures; 2) follow your laboratory protocol regarding the need for review of previously reported patient results; 3) replacement material is available; for ordering, please order through your normal ordering process; and, 4) if you have forwarded any of the affected lots to another laboratory, please provide them with a copy of this communication. Customers or healthcare providers with questions can contact Customer Service at 1-877-422-2688 (24 hours a day, 7 days a week).
- Root cause
- Employee error
- Status
- Terminated
- Product code
- CDP
- Quantity affected
- 7,415 kits
- Distribution
- Worldwide Distribution - USA (nationwide) including Puerto Rico and the states of AL , AR , AZ , CA , CT , FL , GA , IL , IN , KS , LA , MA , MD , MI , MN , MO , MS , MT , NC , NJ , NV , NY , OH , OK
- Date initiated
- 2014-09-11
- Date posted
- 2014-12-03
- Date terminated
- 2016-12-23
- Location
- Lisnamuck Co. Longford, Ireland
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ABBOTT ARCHITECT FREE T3 (K983439) | Abbott Laboratories | 1998-11-20 |