ARCHITECT i2000 System and ARCHITECT i2000 SR wash buffer and wash zone mechanism grounding kit. ARCHITECT System is designed to perform automated chemistry tests utilizing photometry and potentiometric technology; and immunoassay tests utilizing chemiluminescent microparticle assay detection technology.
This recall has been terminated (originally issued November 9, 2009).
- Company
- Abbott Laboratories, Inc
- Recall Initiated
- July 17, 2009
- Posted
- November 9, 2009
- Terminated
- January 26, 2010
- Recall Number
- Z-0132-2010
- Quantity
- 4,526
- Firm Location
- Irving, TX
- Official Source
- View on FDA website ↗
Reason for Recall
Under certain conditions, the product's wash buffer containing sodium azide can come in contact with the wash zone mechanism ground cables on either of the two wash zones. The copper in the ground strap may corrode and form an unstable chemical substance (metal azide) that may be sensitive to direct pressure and impact.
Distribution
Worldwide Distribution
Lot / Code Info
ARCHITECT i2000 System List Number 8C89-01; ARCHITECT i2000SR System System List Number 3M74-01 and 3M74-02; Wash Zone Mechanism Grounding Kit Part Number 7-201369-01; Concentrated Wash Buffer 1 L List Number 6C54-58 and l0 L List number 6C54-88.
Root Cause
Other
Action Taken
A product correction notice was issued to consignees on July 17, 2009. Field representatives were instructed to visit consignees, inspect cables and replace them