QC Sets and Panels: Helix Elite recallZ-1838-2019 · Microbiologics Inc · initiated May 16, 2019
Open, Classified
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 Microbiologics Inc 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
Product is labeled with expiration date of 2021-10-31, should be 2021-03-31.
FDA root cause category: Error in labeling
What the company is doing
The firm initiated the recall by email on 05/20/2019. The notice requested the consignee relabel the product with the correct date and return the completed response form.
Recall details
- Recall number
- Z-1838-2019
- Status
- Open, Classified
- Initiated by the company
- May 16, 2019
- Recalling firm
- Microbiologics Inc
- Quantity
- 22 units
- Product code
- PMN
- FDA submissions
- K190463
- Distribution
- NY, MN, NC, TX, GA, MO, PA, TN, NH, OH, CO
Product description
Cepheid Xpert C. difficile/Epi Control Panel
Code information (models, lots, serial numbers)
UDI: 70845357041370, Lot Number 8200-26
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- QC Sets and Panels: Helix Elite™ 8200 Cepheid Xpert® C. difficile/Epi Control PanelMicrobiologics Inc. · Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays1 recall0 reports
Product lines
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 16, 2026. Text above is shown as published by the FDA.
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