Recall Z-0435-05 ยท LID
Abbott Laboratories, Inc
B12 Reagent (6C09-20 and 6C09-25) for use with the ARCHITECT i2000 and i2000SR Analyzers, List numbers 8C89-01 and 3M74-01. The reagent is manufactured by Abbott Laboratories, Abbott Park, IL. The ARCHITECT instrument is manufactured by Abbott Laboratories, Irving Texas
| Date | Jan 26, 2005 (initiated Dec 14, 2001) |
| Status | Terminated |
| Reason | Falsely elevated B-hCG results can occur when running B12 and B-hCG assays on the same analyzer due to carryover. B-12 results are not impacted. |
| Root cause | Other |
| Action | The firm initiated the recall via letter on December 14 and 16, 2004 directing consignees to perform the two tests on different machines or to contact the customer service representative in the event the consignee only has one machine. |
| Quantity | 6860 units |
| Distribution | The B12 reagent was only distributed to foreign countries including Canada, Germany, Hong Kong, Japan, Dingapore, Australia, and New Zealand |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K984108 | ABBOTT ARCHITECT B12 Abbott Laboratories, Feb 3, 1999 |