B12 Reagent (6C09-20 and 6C09-25) for use with the ARCHITECT i2000 and i2000SR Analyzers, List numbers 8C89-01 and 3M74-
FDA device recall Z-0435-05 · posted 2005-01-26 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories, Inc
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LID
- Quantity affected
- 6860 units
- Distribution
- The B12 reagent was only distributed to foreign countries including Canada, Germany, Hong Kong, Japan, Dingapore, Australia, and New Zealand
- Date initiated
- 2001-12-14
- Date posted
- 2005-01-26
- Date terminated
- 2005-11-02
- Location
- Irving, TX
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ABBOTT ARCHITECT B12 (K984108) | Abbott Laboratories | 1999-02-03 |