Xpert Xpress Strep A, REF:Xprstrepa-CE-10, CE IVD,

FDA device recall Z-0216-2024 · posted 2023-11-02 · Open, Classified

Recall details

Recalling firm

Cepheid

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.

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.

Root cause

Unknown/Undetermined by firm

Status

Open, Classified

Product code

PGX

Quantity affected

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.

Date initiated

2023-04-24

Date posted

2023-11-02

Location

Sunnyvale, CA

Related 510(k) clearances