ARCHITECT Cyclosporine; an in-vitro diagnostic chemiluminescent microparticle immunoassay (CMIA) for the quantitative de
FDA device recall Z-0162-2012 · posted 2011-11-04 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories
- Reason for recall
- The ARCHITECT Cyclosporine assay has the potential to generate falsely elevated or depressed results with patient samples due to precision exceeding the Package Insert claim of <15% total CV. Calibrators and Controls also have the potential to be impacted by the assay imprecision.
- Action taken
- Abbott Laboratories sent a "PRODUCT RECALL" letter dated October 7, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to only run ARCHITECT Cyclosporine using Reaction Vessel (RV) lots manufactured with the same resin as follows: a) RV lots beginning with lot 06083P100 and higher can be used together or, b) RVs lots lower than 06083P100 can be used together. Any RV lot number that does not begin with a zero (e.g. 90032P100) should also be considered lower than 06083P100. Further instructions were included for the accounts to follow when running ARCHITECT Cyclosporine assays. A Customer Reply form was provided to customers to complete and return via fax at 1-800-777-0051. Customers can contact Abbott Customer Service at 1-877-4ABBOTT for questions regarding this notice. A second letter was sent to the accounts on 11/23/11 to simplify the instructions for identifying the Architect Reaction Vessel lots that can be used together for use with the Architect Cyclosporine assay.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- MKW
- Quantity affected
- 8,913 kits
- Distribution
- Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Argentina, Australia, Austria, Bahrain, Bangladesh, Barbados, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Brune
- Date initiated
- 2011-10-07
- Date posted
- 2011-11-04
- Date terminated
- 2012-11-07
- Location
- Abbott Park, IL
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARCHITECT CYCLOSPORINE (K080751) | Fujirebio Diagnostics,Inc. | 2008-09-11 |