Abbott Alinity m SARS-CoV-2 Control Kit Recalled for Failed Internal Control
Abbott is recalling 579 kits of its Alinity m SARS-CoV-2 CTRL control kit after reports of failed internal control errors preventing verification of test accuracy.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall for a diagnostic control kit with reported internal control failures. Although no illnesses or injuries have been reported, the failed internal controls prevent verification of test reliability, creating a risk of unreliable diagnostic results.
Plain-English summary
Abbott Molecular is recalling 579 kits of the Alinity m SARS-CoV-2 CTRL Kit (REF 09N78-085). Each kit contains 12 negative control and 12 positive control vials designed for in vitro diagnostic use in COVID-19 testing.
Reports have been received of an increase in message code 9186 errors, which indicate that internal controls have failed. Internal controls are essential for verifying that a diagnostic test is functioning properly. When internal controls fail, it is not possible to verify that test results are reliable.
The affected lot (530738) was distributed to healthcare facilities across the United States. Affected states include Arizona, California, Connecticut, Florida, Georgia, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, New Jersey, Nevada, New York, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Texas, Washington, and Wisconsin. International distribution was made to Chile and Taiwan.
The recalled product
- 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.
- Manufacturer
- Abbott Molecular, Inc.
- Hazard
- internal-control-failure
- unreliable-test-results
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #530738
- UDI (01)00884999049208(10)530738(17)230527(240)09N78-085.
Distribution
Distributed in 24 states:
- AZ
- CA
- CT
- FL
- GA
- IL
- KS
- KY
- LA
- MA
- MI
- MN
- MO
- NC
- NJ
- NV
- NY
- OK
- PA
- RI
- TN
- TX
- WA
- WI
Related recalls
Same category
- SevereMedline angiography and radiology convenience kits recalled for unapproved design changes
FDA (Devices) · 2026-07-01
- SevereDa Vinci surgical system operative components with E-brake retainer pin defect
FDA (Devices) · 2026-07-01
- ModerateOctopus 4 Tissue Stabilizer incorrectly assembled tubing positions
FDA (Devices) · 2026-07-01
- ModerateOctopus Evolution AS Tissue Stabilizer Model TS2500 Tubing Assembly Issue Recall
FDA (Devices) · 2026-07-01
- SevereMedical Device Surgical Kits with Syringes Recalled for Unapproved Design Changes
FDA (Devices) · 2026-07-01