Date Initiated by Firm | March 08, 2006 |
Date Posted | May 11, 2006 |
Recall Status1 |
Terminated 3 on July 31, 2006 |
Recall Number | Z-0860-06 |
Recall Event ID |
34923 |
510(K)Number | K984108 |
Product Classification |
Radioassay, Intrinsic Factor Blocking Antibody - Product Code LIG
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Product | ARCHITECT B12 Reagent, list 06C09-22 (4 x 100 tests), 06C09-27 (1 x 100 tests); an in vitro diagnostic kit consisting of microparticles, conjugate, assay diluent, pre-treatment 1, pre-treatment 2, and pre-treatment 3; Abbott Laboratories, Abbott Park, IL 60064 |
Code Information |
lot numbers 33079M200, 33079M201 |
Recalling Firm/ Manufacturer |
Abbott Laboratories MPG 100 Abbott Park Rd Abbott Park IL 60064-3502
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For Additional Information Contact | Abbott Customer Support 877-422-2688 |
Manufacturer Reason for Recall | The 30-day onboard storage information is not included in the barcode labels for these two lots. As a result, the ARCHITECT system software is unable to track how long a reagent kit has been stored onboard the ARCHITECT instrument. |
FDA Determined Cause 2 | Other |
Action | Abbott affiliates in Canada, Germany and Australia were e-mailed copies of the recall letter on 3/8/06 for translation where needed and dissemination to their accounts receiving the suspect lots. The end users were advised that the 30-day onboard storage information is not included in the barcode for the two lots. As a result the ARCHITECT system software is unable to track how long the reagent kit has been stored onboard. The accounts were instructed to manually track the onboard storage time for the two lots, and discard the kits after 30 days of onboard storage. |
Quantity in Commerce | 135 kits |
Distribution | Canada, Germany and Australia |
Total Product Life Cycle | TPLC Device Report |
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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 = LIG
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