Abbott Molecular, Inc.: Abbott Alinity m SARS-CoV-2 CTRL Kit, REF 09N78-085, each kit contains 12 x 1.3mL CTRL - and 12 x 1.3 mL CTRL +, For In Vitro Diagnostic Use.

Hazard

Reports received of an increase of message code 9186 (internal control failed) when using the kit.

Details from the source

Reason for recall: Reports received of an increase of message code 9186 (internal control failed) when using the kit. Distribution: Distribution was made to AZ, CA, CT, FL, GA, IL, KS, KY, LA, MA, MI, MN, MO, NC, NJ, NV, NY, OK, PA, RI, TN, TX, WA, and WI. There was government distribution but no military distribution. Foreign distribution was made to Chile and Taiwan. Quantity: 579 kits Lot/code info: Lot #530738, UDI (01)00884999049208(10)530738(17)230527(240)09N78-085.

UPC codes

00884999049208

Source

Official record: FDA (Device enforcement) ↗

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