VIDAS CMV IgG Assay recallZ-1047-04 · bioMerieux · initiated Jun 9, 2004
Terminated All recalls posted in July 2004
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 bioMerieux 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
The product may give false positive results.
FDA root cause category: Other
What the company is doing
Consignees were notified by letter on June 9, 2004.
Recall details
- Recall number
- Z-1047-04
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jun 9, 2004
- Posted by the FDA
- Jul 20, 2004
- Recalling firm
- bioMerieux
- Quantity
- 148 units
- Product code
- LFZ
- FDA submissions
- K920661
- Distribution
- AR, CA, FL, GA, IL, IN, KY, MA, MD, MN, MS, MT, NC, NE, NH, NJ, NY, OH, PA, RI, SD, TN, VA.
Product description
VIDAS CMV IgG Assay
Code information (models, lots, serial numbers)
Catalog #30 204, Lot #782887501
Other devices under the same FDA submission
1 device cleared under K920661 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- VIDAS® CMV IgG 30204-01Biomerieux SA · Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus3 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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