Abbott Molecular, Inc.: Medical Device Recall in 2022 - (Recall #: Z-1679-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: August 19, 2022

Date Posted: September 14, 2022

Recall Number: Z-1679-2022

Event ID: 90789

Reason for Recall:

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

Status: Ongoing

Product Quantity: 579 kits

Code Information:

Lot #530738, UDI (01)00884999049208(10)530738(17)230527(240)09N78-085.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated