Recalls / —
—#50969
Product
Roche COBAS Integra DIG, Digoxin Reagent for use on the COBAS INTEGRA models 400, 400 plus, 700 and 800 analyzers, as well as, Cobas c 501 analyzer; Catalog Number 20737836322.
- FDA product code
- KXT — Enzyme Immunoassay, Digoxin
- Device class
- Class 2
- Medical specialty
- Clinical Toxicology
- 510(k) numbers
- K851032
- Affected lot / code info
- All Reagent Lots (including Lots 67941901, exp. 4/30/07; 68139201, exp. 6/30/07 and 68156201, exp. 8/31/07)
Why it was recalled
The lower detection limit (LDL) may be a higher value than stated in the labeling. Note: To resolve this issue, the Digoxin LDL claim has been revised to 0.3 ng/mL for all reagent lots.
Root cause (FDA determination)
Other
Action the firm took
A recall letter dated 3/16/07 was sent to each consignee advising them that the LDL claim in the label has been revised to 0.3 ng/ml for all reagent lots.
Recalling firm
- Firm
- Roche Diagnostics Corp.
- Address
- 9115 Hague Rd, Indianapolis, Indiana 46256-1025
Distribution
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2007-03-16
- Posted by FDA
- 2007-04-13
- Terminated
- 2008-06-12
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #50969. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.