ONLINE TDM N-acetylprocainamide, Part number 04642520190 N- acetylprocainamide reagent Roche Diagnostics Corporation Ind
FDA device recall Z-2386-2010 · posted 2010-09-08 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Operations, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- LAN
- Quantity affected
- 40 kits
- Distribution
- Nationwide Distribution: USA states of AL, CT, NY, PA, and TX.
- Date initiated
- 2010-02-05
- Date posted
- 2010-09-08
- Date terminated
- 2010-11-01
- Location
- Indianapolis, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TDM N-ACETYLPROCAINAMIDE (K060738) | Roche Diagnostics Corp. | 2006-08-16 |