Architect Tacrolimus Reagent Kit; an in-vitro diagnostic chemiluminescent microparticle immunoassay (CMIA) for the quant
FDA device recall Z-0068-2011 · posted 2010-10-15 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories
- Reason for recall
- There are reagent barcode read errors when using reagent lot 86599M500 due to the print quality of the barcode.
- Action taken
- Abbott Laboratories sent a "Product Recall Immediate Action Required" letter dated September 7, 2010, to all customers. The letter described product, problem and action to be taken by customers. The customers were instructed to determine if they are currently using and/or have inventory of lot 86599M500; discontinue use of and destroy any remaining inventory; inform and provide copies of letter to other laboratories if appropriate; retain the letter for laboratory records and complete and return the Customer Reply Immediate Action Required form via fax at 1-800-777-0051 or email QAGCO@abbott.com. IMPORTANT NOTE: If you do not currently have replacement material than you may continue to use this reagent lot until your laboratory receives replacement material. Upon receipt of the replacement material, discontinue use of and discard lot 86599M500 and switch to the replacement material. Contact Abbott Customer service for replacement material (1-877-4ABBOTT, Option 1). If you or any of the health care providers you serve have any questions regarding this information, U.S. customers should call Customers Service at 1-877-4ABBOTT. Customers outside of the U.S., please contact your local Customer Service representative.
- Root cause
- Other
- Status
- Terminated
- Product code
- MLM
- Quantity affected
- 1,995 kits
- Distribution
- Worldwide distribution: USA and countries including Puerto Rico, Argentina, Australia, Austria, Belarus, Belgium, Bosnia, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, Croatia, Czech Republic
- Date initiated
- 2010-09-07
- Date posted
- 2010-10-15
- Date terminated
- 2011-05-13
- Location
- Abbott Park, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARCHITECT TACROLIMUS: MODEL 1L77 (K070820) | Fujirebio Diagnostics,Inc. | 2007-08-01 |