—#88804

Product

ONLINE TDM N-acetylprocainamide, Part number 04642520190 N- acetylprocainamide reagent Roche Diagnostics Corporation Indianapolis, IN.

FDA product code: LAN — Enzyme Immunoassay, N-Acetylprocainamide
Device class: Class 2
Medical specialty: Clinical Toxicology
510(k) numbers: K060738
Affected lot / code info: 14456200

Why it was recalled

The N-acetylprocainamide reagent lot 14456200 shows an incorrect expiration date of 7/31/2011. The correct expiration date for the lot is 1/31/2011.

Root cause (FDA determination)

Error in labeling

Action the firm took

Roche issued an "Urgent Medical Device Removal" letter dated February 2010 to consignees identifying the issue and affected product. Customers were requested to complete the attached form and return in to the firm to obtain replacement product. After receipt of replacement reagent, the customer should discard the affected product product. If unaffected lots are not available, customers may use the affected lot until replacement product is received. Use of the affected product before the corrected expiration date of January 31, 2011 should not produce erroneous test results. Roche Diagnostics Technical Support can be contacted at 1-800-428-2336.

Recalling firm

Firm: Roche Diagnostics Operations, Inc.
Address: 9115 Hague Road, Indianapolis, Indiana 46256

Distribution

Distribution pattern: Nationwide Distribution: USA states of AL, CT, NY, PA, and TX.

Timeline

Recall initiated: 2010-02-05
Posted by FDA: 2010-09-08
Terminated: 2010-11-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #88804. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.