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. Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Abbott Molecular, Inc.
Lot Codes / Batch Numbers
Lot #530738, UDI (01)00884999049208(10)530738(17)230527(240)09N78-085.
Products Sold
Lot #530738, UDI (01)00884999049208(10)530738(17)230527(240)09N78-085.
Abbott Molecular, Inc. is recalling Abbott Alinity m SARS-CoV-2 CTRL Kit, REF 09N78-085, each kit contains 12 x 1.3mL CTRL - and 12 x 1. due to Reports received of an increase of message code 9186 (internal control failed) when using the kit.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Reports received of an increase of message code 9186 (internal control failed) when using the kit.
Recommended Action
Per FDA guidance
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 all control levels prior to reporting results as specified in the associated package Insert. A Customer Reply Form was enclosed for completion and return. If the consignee has forwarded any kits of the affected lot to other laboratories, they are instructed to inform them of the recall, provide them a copy of the letter, and have them take the necessary actions listed. The letter also instructs the consignee to inform their laboratory personnel of the issue and retain a copy of the communication for further reference.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, CA, CT, FL, GA, IL, KS, KY, LA, MA, MI, MN, MO, NV, NJ, NY, NC, OK, PA, RI, TN, TX, WA, WI
Page updated: Jan 10, 2026