Z-1679-2022 Class II Ongoing
FDA device recall Z-1679-2022 was initiated by Abbott Molecular, Inc. on August 19, 2022 and is designated Class II. Reason for recall: Reports received of an increase of message code 9186 (internal control failed) when using the kit. The recall status is ongoing. Affected quantity: 579 kits.
Recall Details
- Product Type
- Devices
- Report Date
- September 14, 2022
- Initiation Date
- August 19, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 579 kits
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.
Reason for Recall
Reports received of an increase of message code 9186 (internal control failed) when using the kit.
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.
Code Information
Lot #530738, UDI (01)00884999049208(10)530738(17)230527(240)09N78-085.