Roche PTH (parathyroid hormone test system) for use in conjunction with Roche cobas e 411, cobas e 601, Elecsys 1010, Elecsys 2010 and Modular E 170 analyzers; catalog no. 11972103122.
This recall has been terminated (originally issued May 16, 2007).
- Company
- Roche Diagnostics Corp.
- Recall Initiated
- April 19, 2007
- Posted
- May 16, 2007
- Terminated
- June 11, 2008
- Recall Number
- Z-0810-2007
- Quantity
- 14,503
- Firm Location
- Indianapolis, IN
- Official Source
- View on FDA website ↗
Reason for Recall
Negative bias caused by hemolysis interference at the low end of the reference range could cause erroneous diagnosis of hypoparathyroidism.
Distribution
Nationwide.
Lot / Code Info
Lots 17723501, exp. 1/31/08; 17723502, exp. 1/31/08; 17642601, exp. 11/30/07; 17642602, exp. 11/30/07; 17450901, exp. 5/31/07; 17450902, exp. 5/31/07 and 17450903, exp. 5/31/07.
Root Cause
Other
Action Taken
The firm issued a letter dated 04/19/07 to all users informing them of the change in the hemoglobin interference claim.
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