Alinity m recallZ-1679-2022 · Abbott Molecular, Inc. · initiated Aug 19, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Abbott Molecular, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Reports received of an increase of message code 9186 (internal control failed) when using the kit.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-1679-2022
- Status
- Open, Classified
- Initiated by the company
- Aug 19, 2022
- Recalling firm
- Abbott Molecular, Inc.
- Quantity
- 579 kits
- Product code
- QJR
- 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.
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.
Code information (models, lots, serial numbers)
Lot #530738, UDI (01)00884999049208(10)530738(17)230527(240)09N78-085.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Alinity m 09N78-085Abbott Molecular Inc. · Reagents, 2019-novel coronavirus nucleic acid1 recall42 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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