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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
- Affected units
- 579
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
Related recalls
Same manufacturer · Abbott Molecular, Inc.
See all →- HighAbbott Alinity m Resp-4-Plex AMP Kit Multiplex PCR Test Recall
FDA (Devices) · 2025-05-21
- HighAbbott Alinity m Resp-4-Plex Amplification Kit Recall
FDA (Devices) · 2025-05-21
- ModerateAlinity m System nucleic acid testing instruments recalled for liquid spillage
FDA (Devices) · 2025-04-30
- HighAbbott Alinity m HPV test kit control failures from iron contamination
FDA (Devices) · 2024-11-06
- HighAbbott STI and HPV Test Kits Recalled for Quality Control Failures
FDA (Devices) · 2024-11-06
Similar recalls
- SevereAbbott Alinity m SARS-CoV-2 Test Kit Recalled for Potential False Positives
FDA (Devices) · 2021-10-20
- SevereAbbott Alinity m SARS-CoV-2 Amp Kit Recalled for Potential False Positive Results
FDA (Devices) · 2021-10-20
- SevereAbbott SARS-CoV-2 Diagnostic Kit Recalled for Risk of False Positive Results
FDA (Devices) · 2021-10-20
- HighAbbott STI and HPV Test Kits Recalled for Quality Control Failures
FDA (Devices) · 2024-11-06
- HighSARS-CoV-2 Antigen Calibrators May Produce False Positive Test Results
FDA (Devices) · 2021-08-18
- HighAbbott Alinity m Resp-4-Plex Amp Kit Recalled for False Positive Results
FDA (Devices) · 2022-12-28