Xpert Xpress Strep A recall
Xpert Xpress Strep A, REF:Xprstrepa-CE-10, CE IVD,
Why was Xpert Xpress Strep A recalled?
pipettes packaged in Strep A test may fail to dispense an adequate sample volume which could result in "invalid" results or no result test results.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
UDI: (01)07332940006297/ Lot: 23815
- Product
- Xpert Xpress Strep A, REF:Xprstrepa-CE-10, CE IVD,
- Recalling firm
- Cepheid
- Quantity
- 1,413 kits ( 10 test per kit)
- Distribution
- Worldwide distribution - US Nationwide and the countries of Costa Rica, Ireland, Estonia, United Kingdom, Germany, Italy, Greece, Poland, Switzerland, Hong Kong, United Arab Emirates.
- Recall date
- November 8, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)