Roche ISE Internal Standard Gen.2 for use on Roche cobas c systems, Roche Diagnostics, Inc., Indpls., IN; Catalog no. 04522320190. Product is an in vitro diagnostic.
This recall has been terminated (originally issued January 6, 2009).
- Company
- Roche Diagnostics Corp.
- Recall Initiated
- September 15, 2008
- Posted
- January 6, 2009
- Terminated
- December 1, 2009
- Recall Number
- Z-0542-2009
- Quantity
- 7909
- Firm Location
- Indianapolis, IN
- Official Source
- View on FDA website ↗
Reason for Recall
Test results, low: Sodium, potassium and chloride results on the cobas 6000 ISE unit may exhibit a downward drift in controls and patient samples within the recommended calibration interval of 24 hours. For further information, please contact Roche Diagnostics Corporation by telephone at 800-428-2336.
Distribution
Nationwide Distribution.
Lot / Code Info
Lot numbers: 60258801, 60258601, 60145701, 60145601, 69921901, 69921801, 69786201, 69922001, 69786101, 69676101, 69509701, 69431901, 69357601, 69342001, 69246501, 68966601 and 68871601.
Root Cause
Package design/selection
Action Taken
Consignees were notified by letter dated 9/15/08, which provided a work-around for them to use until the problem can be permanently resolved. The letter was entitled "URGENT MEDICAL DEVICE CORRECTION." For further information, please contact Roche Diagnostics Corporation by telephone at 800-428-2336.