FDA recall Z-1679-2022

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.

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.

Key facts

Status

Ongoing

Initiation date

2022-08-19

Report date

2022-09-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Des Plaines, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1679-2022