Cepheid Xpert Xpress Strep A, REF:Xprstrepa-CE-10, CE IVD, Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Xpert Xpress Strep A, REF:Xprstrepa-CE-10, CE IVD,
Brand
Cepheid
Lot Codes / Batch Numbers
UDI: (01)07332940006297/ Lot: 23815
Products Sold
UDI: (01)07332940006297/ Lot: 23815
Cepheid is recalling Xpert Xpress Strep A, REF:Xprstrepa-CE-10, CE IVD, due to 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.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026