Recall Z-0216-2024 ยท PGX Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System
Cepheid
Xpert Xpress Strep A, REF:Xprstrepa-CE-10, CE IVD,
| Date | Nov 2, 2023 (initiated Apr 24, 2023) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Unknown/Undetermined by firm |
| Action | On April 28, 2023, Cepheid issued a Important product recall notification to affected consignees via FedEx. In addition to informing consignees about the recall, Cepheid ask consignees to take the following action: 2. If, upon following this guideline for proper use of the pipette you determine that your pipette fails to aspirate an adequate volume of liquid, repeat the steps using a new pipette. 3. We ask that you acknowledge receipt of this Important Product Notice by responding via a web request from https://www.cepheid.com/streppipette (for US customer only) or by completing the enclose |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K172126 | Xpert Xpress Strep A Cepheid, Sep 25, 2017 |