Recalls / —

—#96434

Product

Acetaminophen Test System for use on the Roche/Hitachi, part number 03255379190, Roche Diagnostics Corporation, Indianapolis, IN. For the quantitative determinations of toxic levels of acetaminophen in human serum or plasma on Roche automated clinical analyzers.

FDA product code

LDP — Colorimetry, Acetaminophen

Device class

Class 2

Medical specialty

Clinical Toxicology

510(k) numbers

K013757

Affected lot / code info

11021000, 11071000 and 11070900.

Why it was recalled

The current product labeling for Acetaminophen does not provide specific interference information for bilirubin, hemoglobin or lipemia. Additional testing has been performed to quantify the impact of these interferences at different concentrations and different levels of acetaminophen. Low serum concentrations of acetaminophen were included in the study.

Root cause (FDA determination)

Other

Action the firm took

The firm, Roche, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated December 07, 2010 to its customers. The letter described the product, problem, and action to be taken. The customers were instructed to be aware that endogenous interferents (i.e., bilirubin, hemolysis, and/or lipemia) may produce a falsely elevated value for samples containing concentrations less than 50 ug/ml of acetaminophen; complete and return the attached UMDC Faxback Form for Acetaminophen Assay via fax to 1-817-868-5343, and file this letter for future reference. The firm ask the customers to please consult with the physician or pathologist at their facility to determine specific clinical implications for their patients. The firm is also updating the product labeling to include information regarding the interference of icteric, hemolytic or lipemic samples. Please contact Roche Diagnostics Technical Support at 1-800-428-2336 if you have any questions about the information contained in this Urgent Medical Device Correction (UMDC).

Recalling firm

Firm

Roche Diagnostics Operations, Inc.

Address

9115 Hague Road, Indianapolis, Indiana 46256-1025

Distribution

Distribution pattern

Nationwide distribution.

Timeline

Recall initiated

2010-12-07

Posted by FDA

2011-03-16

Terminated

2012-03-13

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #96434. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.