The TaqPath RT-PCR COVID-19 Kit with Applied recall: Software Issue
The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem's COVID-19 Interpretive Software v1.2 for 7500 RTPCR instruments, includes the assays and…
Why was The TaqPath RT-PCR COVID-19 Kit with Applied recalled?
COVID-19 Interpretive Software issues that may cause: 1) the risk of invalid or inconclusive tests/false negative and potentially increasing the retesting burden on customers. 2) false positive results due to improper vortexing.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Product SKU: Product Lot/Serial#: Release Date: 100093765 Version 1.2 (EUA) 28-APR-20 100087427 Version 2.2 (EUA) 11-MAY-20 100093771 Version 1.2 (CE-IVD) 28-APR-20 100094318 Version 2.2 (CE-IVD) 19-MAY-20 Applied Biosystems" COVID-19 Interpretive Software Version 1.2 was the first version of software developed in a dedicated CE-IVD Edition. Previous versions are shared with the FDA-EUA version of the device.
- Product
- The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem's COVID-19 Interpretive Software v1.2 for 7500 RTPCR instruments, includes the assays and…
- Recalling firm
- Life Technologies Corporation
- Quantity
- NA
- Distribution
- US: AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NM, NY, NV, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. OUS: Afghanistan, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Botswana, Brazil, Cameroon, Canada, Cypress, Estonia, France, Georgia, Germany, Greece, Guadeloupe, Hungary, India, Indonesia, Ireland, Israel, Italy, Kenya, Kuwait, Lebanon, Mozambique, Namibia, New Zealand, Oman, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom, United Republic of Tanzania, and Vietnam.
- Recall date
- September 23, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)