Recall Z-1679-2022 ยท QJR Reagents, 2019-Novel Coronavirus Nucleic Acid
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.
| Date | Aug 19, 2022 |
| Status | Open, Classified |
| Reason | Reports received of an increase of message code 9186 (internal control failed) when using the kit. |
| Root cause | Under Investigation by firm |
| Action | The firm issued recall letters dated 8/19/2022 via FedEx priority overnight express on 8/19/2022. The letters provided the background, potential impact, and necessary actions. The necessary actions included contacting Abbott Customer Support for replacement of any unused kits in the consignee's inventory of the affected lot number and discard any inventory in their possession. If replacement inventory is not available, the consignee was told they may continue to use the affected product until replacement material is obtained. They are to ensure that valid Control values are obtained for al |
| Quantity | 579 kits |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.