Z-1679-2022Class II

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...

Name: Z-1679-2022 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...
Creator: Abbott Molecular, Inc.
Published: 2022-08-19
License: https://open.fda.gov/license/

Abbott Molecular, Inc. / initiated 2022-08-19 / Open, Classified

FDA source

Abbott Molecular, Inc. began a recall of 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 on 2022-08-19. FDA classified it as Class II and gives the reason as "Reports received of an increase of message code 9186 (internal control failed) when using the kit". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1679-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-08-19
Posted: 2022-09-06
Recalling firm: Abbott Molecular, Inc.
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.
Product code: QJR Reagents, 2019-Novel Coronavirus Nucleic Acid
Reason for recall: Reports received of an increase of message code 9186 (internal control failed) when using the kit.
FDA 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 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.
Quantity in commerce: 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.
Product codes and lots: Lot #530738, UDI (01)00884999049208(10)530738(17)230527(240)09N78-085.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1679-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1679-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-14	2022-09-06

Product code QJR

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)