medical Class II Updated 2022-09-14

Abbott Molecular, Inc. recalls Abbott Alinity m SARS-CoV-2 CTRL Kit, REF 09N78-085, each ki

Recalled Product

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 / Issue

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

Issued by

FDA

Affected States: AZ, CA, CT, FL, GA, IL, KS, KY, LA, MA, MI, MN, MO, NC, NJ, NV, NY, OK, PA, RI, TN, TX, WA, WI
Lot/Code Info: Lot #530738, UDI (01)00884999049208(10)530738(17)230527(240)09N78-085.
View official government recall

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