Cepheid: Xpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158 Xpert SA Nasal Complete kit; 10 test kit: A collection of reagents and other associated materials intended to b

Hazard

As a result of Post-Market half-time stability testing, false negative test result was observed for a positive sample type.

Details from the source

Reason for recall: As a result of Post-Market half-time stability testing, false negative test result was observed for a positive sample type. Distribution: U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, WA, WI, WV, and WY. Quantity: 4,132 kits Lot/code info: Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158 Lot Numbers: 27815 27816 Batch Numbers: 1001424179 1001424181

UPC codes

07332940000158

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.