Recall Z-1838-2019
Microbiologics Inc · initiated May 16, 2019
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
Cepheid Xpert C. difficile/Epi Control Panel
Codes / lots: UDI: 70845357041370, Lot Number 8200-26
Reason for recall
Product is labeled with expiration date of 2021-10-31, should be 2021-03-31.
FDA-determined cause: Error in labeling
Action taken
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.
Details
- Recall number
- Z-1838-2019
- Initiated
- May 16, 2019
- Product code
- PMN – Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
- Quantity
- 22 units
- Distribution
- NY, MN, NC, TX, GA, MO, PA, TN, NH, OH, CO
- Recalling firm
- Microbiologics Inc, Saint Cloud, MN