Xpert Xpress Strep A, XPRSTREPA-10, P/N: 302-2294 IVD, Rx Only
- Company
- Cepheid
- Recall Initiated
- April 24, 2023
- Posted
- November 2, 2023
- Recall Number
- Z-0215-2024
- Quantity
- 89,958 kits ( 10 test per kit)
- Firm Location
- Sunnyvale, CA
Reason for Recall
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.
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.
Lot / Code Info
UDI: (01)07332940006372/ Lots: 23718 23719 23720 10309 23201 23305 23308 23312 23314 23315 23401 23402 23403 23404 23405 23406 23407 23501 23504 23505 23506 23408 23410 23510 23411 23604 23605 23607 23608 23609 23610 23611 23612 23701 23702 23703 23705 23706 23707 23708 23709 23710 23711 23712 23714 23716 23717 23113 23316 23912 24112 23820 24704 24302 24307 24507 24508 24511 23822 23823 23824 24512 24513 24514 23825 24313 24515 24516 24517 24805
Root Cause
Unknown/Undetermined by firm
Action Taken
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 enclosed Customer Response Form (email or Fax). In addition, replacement pipettes, if needed, can be requested via the above mentioned process. Please complete this activity within 10 days, so we are assured you have received this important communication. The Customer Response Form can be emailed to CFQ@cepheid.com or faxed to +1 (408) 716-3143. 4. Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forwarded any of the affected product(s) listed above to another laboratory, please provide them a copy of this letter.