Z-2386-2010

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

Name: Z-2386-2010 ONLINE TDM N-acetylprocainamide, Part number 04642520190 N- acetylprocainamide reagent Roche Diagnostics...
Creator: Roche Diagnostics Operations, Inc.
Published: 2010-02-05
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2010-02-05 / Terminated / root cause: labeling and UDI

FDA source

Roche Diagnostics Operations, Inc. began a recall of ONLINE TDM N-acetylprocainamide, Part number 04642520190 N- acetylprocainamide reagent Roche Diagnostics Corporation Indianapolis, IN on 2010-02-05. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2386-2010
Status: Terminated
Initiated: 2010-02-05
Posted: 2010-09-08
Terminated: 2010-11-01
Recalling firm: Roche Diagnostics GmbH
Product: ONLINE TDM N-acetylprocainamide, Part number 04642520190 N- acetylprocainamide reagent Roche Diagnostics Corporation Indianapolis, IN.
Product code: LAN Enzyme Immunoassay, N-Acetylprocainamide
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.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: 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.
Quantity in commerce: 40 kits
Distribution: Nationwide Distribution: USA states of AL, CT, NY, PA, and TX.
Product codes and lots: 14456200

Product code LAN

K060738Class IITdm N-AcetylprocainamideRoche Diagnostics Corp. / cleared 2006-08-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)