Summary
The FDA issued a Class II for Xpert Xpress Strep A, XPRSTREPA-10, P/N: 302-2294 IVD, Rx Only by Cepheid. 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..
Details
Source
Device Recall
External ID
Z-0215-2024
Action Date
2023-11-08
Status
Ongoing
Category
device
Product Description
Xpert Xpress Strep A, XPRSTREPA-10, P/N: 302-2294 IVD, Rx Only
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
Quantity Affected: 89,958 kits ( 10 test per kit)
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-04-24
Company
Sunnyvale, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 156 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Cepheid has 24 FDA actions in our database, including 7 recalls and 17 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Cepheid) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Cepheid have FDA actions?
Cepheid has 24 FDA actions in our database, including 7 recalls and 17 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0215-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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