Recall Z-2487-2021 ยท OHQ Multi-Analyte Controls Unassayed
Microbiologics Inc
SARS-CoV-2 Process Control (Swab) - Product Usage: intended for use as an external, non-viable control material to evaluate the performance of nucleic acid tests that detect SARS-CoV-2 virus.
| Date | Aug 20, 2021 |
| Status | Terminated |
| Reason | The product indicated is contaminated with a plasmid DNA that contains the target SARS-CoV-2 sequences. |
| Root cause | Material/Component Contamination |
| Action | On AUGUST 23, 2021 THE FIRM SENT THE FOLLOWING INSTRUCTIONS TO THEIR CONSIGNEES.: INSTRUCTIONS: 1. REVIEW lab procedures to understand how this information affects your usage 2. USE OR DISCARD depending on your lab procedures and how this information affects your usage. 3. COMPLETE the response form provided. 4. RETURN the response form to recall@microbiologics.com 5. KEEP this letter for your records. 6. CONTACT Microbiologics to discuss possible alternatives if replacement is needed Microbiologics is dedicated to ensuring the success of your quality control processes. Please contact our Rec |
| Quantity | 127 |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of CA, FL, GA, IL, MD, MT, MN, NC, NY, NV, OR, TN, TX,UT, WA and WI. The countries of Austria, Canada, Colombia, France, Germany, Hong Kong, India, Ireland, Italy, Japan and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.