| Class 3 Device Recall ARCHITECT Folate Specimen Diluent | |
Date Initiated by Firm | December 16, 2003 |
Date Posted | July 20, 2004 |
Recall Status1 |
Terminated 3 on July 20, 2004 |
Recall Number | Z-0364-04 |
Recall Event ID |
27978 |
510(K)Number | K023397 |
Product Classification |
unknown device name - Product Code CGN--
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Product | ARCHITECT Folate Specimen Diluent, List 6C12Y, 5.5 mL (100 tests) and 25.9 mL (500 tests) bottles containing TRIS buffer with protein stabilizer, contained in ARCHITECT Folate Reagent Kit (Lists 6C12-20, 6C12-25, 6C12-30); Abbott Laboratories, Abbott Park, IL 60064 USA |
Code Information |
List 6C12Y: lots 06537M100Y, 09888M100Y, 06537M101Y, 05081M100Y, 07465M300Y and 10587M200Y. These diluent lots were packaged in the following reagent kit lots: List 6C12-20 (4 x 100 tests), lots06537M100 and 09888M100; List 6C12-25 (100 tests), lots 06537M101and 05081M100; List 6C12-30 (4 x 500 tests), lots 07465M300 and 10587M200. |
Recalling Firm/ Manufacturer |
Abbott Laboratories HPD/ADD/GPRD 100/200 Abbott Park Road Abbott Park IL 60064
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Manufacturer Reason for Recall | The is an increase in the number of control values out of range low, and diluted patient specimens may yield lower than expected results. |
FDA Determined Cause 2 | Other |
Action | Abbott notified their international affiliates via e-mail on 12/16/03 and 1/5/04. Device recall letters dated 12/16/03 and 12/31/03 will be sent to the end users by the affiliates, informing them of the unapproved serum albumin used to manufacture the folate products, and listing the impact to performance for each affected components. There are separate customer recall letters for each assay platform -- ARCHITECT, AxSYM and IMx. |
Quantity in Commerce | 2,141 kits |
Distribution | There was no U.S. distribution. The products were shipped internationally through Abbott affiliates in Canada, Germany, Singapore, Hong Kong, Australia, Brazil, New Zealand, Columbia, Chile, Uruguay, United Kingdom, Venezuela, Dominican Republic, Argentina and Curacao. |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = CGN--
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