Roche VALP2, Online TDM Valproic acid , for use with the… recallZ-0920-2007 · Roche Diagnostics Corp. · initiated Apr 30, 2007
Terminated All recalls posted in June 2007
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Roche Diagnostics Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Probe Wash: Reported results may have a positive bias because inadequate analyzer probe wash instructions may result in carry-over from the following assays: Creatinine Kinase L and Creatine Kinase-MBL.
FDA root cause category: Other
What the company is doing
Consignees were issued a recall letter dated 4/30/07 instructing them to perform a R2 reagent probe wash when using CKL and CKMBL with the vancomycin or valproic acid assays.
Recall details
- Recall number
- Z-0920-2007
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Apr 30, 2007
- Posted by the FDA
- Jun 9, 2007
- Recalling firm
- Roche Diagnostics Corp.
- Quantity
- 992
- Product code
- LEG
- FDA submissions
- K060690
- Distribution
- Nationwide.
Product description
Roche VALP2, Online TDM Valproic acid , for use with the Roche/Hitachi Cobas c 501 analyzer; Catalog No.04491041190.
Code information (models, lots, serial numbers)
Lots 144107, exp. 9/30/2007; 144166, exp. 1/31/2008, and 144208, exp. 6/30/2008
Other devices under the same FDA submission
2 devices cleared under K060690 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Valproic Acid 4491041190Roche Diagnostics GmbH · ENZYME IMMUNOASSAY, VALPROIC ACID3 reports
- Valproic Acid 5108438190Roche Diagnostics GmbH · ENZYME IMMUNOASSAY, VALPROIC ACID2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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